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Adverse Event Report

BALLARD MEDICAL PRODUCTS MIC GASTROSTOMY TUBE ENTERAL FEEDING TUBE   back to search results
Catalog Number 100-14LV
Event Date 08/23/1999
Event Type  Death   Patient Outcome  Death;
Event Description

A four-month-old male with arthrogryposis (disorder in which one or more joints became fused together and cannot bend) who also had a nissan fundoplication and a tracheostomy, had used an enteral feeding tube since three weeks after birth. Medications included tylenol, robinol, ferinol, and nystatin. It was reported that the first feeding tube the child had lasted for three months. The mfr of this tube is not known. Four of the mfr's feeding tubes lasted only 48 to 96 hours a piece before the balloons deflated. The child was taken to the emergency room on three different days for tube changes because formula was leaking from the stoma area. The child had been receiving 5. 5 ounces of formula every 4 hours. The amount of feeding was not changed and stomach residuals were checked prior to each feeding. Tube placement was verified with contrast medium during an emergency room visit. No fever was noted during any of these emergency room visits. However, the child was on a daily regimen of tylenol. On 8/19, x-rays indicated that the child had two fractured femurs probably due to the arthrogryposis. A body cast was applied on 8/20. A small opening had been left in the cast in the stomach area to accommodate the feeding tube and the back area was open to facilitate diaper changes. On 8/22, the child's mother reported to the gastrointestinal physician that the child had diarrhea and black tarry stools. Stools had been normal until this time. On 8/23, the child had a fever of 101 degrees and was given tylenol at home. On that day the home nurse was able to administer less than half of the child's normal feeding amount. The child had no fever during an office visit with the physician later in the day and the mother and child returned home. Once at home, the mother noticed that the child's stomach had become extremely distended and purple. She was getting ready to return to the physician when the child suddenly died. Since the child died at home, all feeding supplies were confiscated by the police. A verbal report from the coroner to the mother indicated that the child died of a massive infection due to an ileus (intestinal obstruction, usually of the small bowel) and that they "are not looking at the tube" (mfr's device) as a contributing factor in the death. The mfr does not feel that this is a reportable event, but co is filing the report due to the circumstances involved in the incident.

 
Manufacturer Narrative

Device not returned to mfr.

 
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Brand NameMIC GASTROSTOMY TUBE
Type of DeviceENTERAL FEEDING TUBE
Baseline Brand NameMIC GASTROSTOMY TUBE
Baseline Generic NameENTERAL FEEDING TUBE
Baseline Catalogue Number100-14LV
Baseline Device FamilyGASTROSTOMY TUBE
Baseline Device 510(K) NumberK842076
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed08/14/1984
Manufacturer (Section F)
BALLARD MEDICAL PRODUCTS
12050 lone peak pkwy.
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
12050 lone peak pkwy.
draper UT 84020
Manufacturer (Section G)
BALLARD MEDICAL PRODUCTS
1999 alvin ricken dr
pocatello ID 83201
Manufacturer Contact
e. chamberlain, ph.d.
12050 lone peak pkwy
draper , UT 84020
(801) 572 -6800
Device Event Key235306
MDR Report Key242878
Event Key227861
Report Number1719891-1999-00017
Device Sequence Number1
Product CodeKNT
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/30/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number100-14LV
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/31/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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