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Adverse Event Report

BALLARD MEDICAL PRODUCTS TRACH CARE TRACHEOBRONCHIAL SUCTION CATHETER   back to search results
Catalog Number 221079
Event Date 10/01/2002
Event Type  Malfunction  
Event Description

A report was received that during a suction procedure, the catheter of the closed suction system separated from the thumb valve. No additional data were received from subsequent inquiries.

 
Manufacturer Narrative

The product was returned without the lock ring on the male end of the closed suction system double swivel elbow. The male insert was still in the elbow. The device was evaluated and the alleged failure could not be duplicated. The cause of event is unk. The investigation confirmed that there was sufficient solvent (bond) on the elbow inside diameter where the male lock ring would have been. Co was unable to determine if the male lock ring was lost during transit or not used during assembly. No conclusion can be drawn. Since the manufacture of this lot, 100% inspection in the assembly process has been implemented.

 
Search Alerts/Recalls

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Brand NameTRACH CARE
Type of DeviceTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Brand NameTRACH CARE DIR. TIP, DBL LUMEN, DBL SWIVEL
Baseline Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Catalogue Number221079
Baseline Device FamilyTRACH CARE
Baseline Device 510(K) NumberK872621
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)60
Date First Marketed01/01/1987
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 Contact
sally herrick
12050 lone peak parkway
draper , UT 84020
(801) 523 -5105
Device Event Key416159
MDR Report Key427144
Event Key404074
Report Number1719891-2002-00092
Device Sequence Number1
Product CodeBSY
Report Source Manufacturer
Source Type Foreign,User facility,Distributor
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 10/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2006
Device Catalogue Number221079
Device LOT Number147305
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/14/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/11/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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