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Adverse Event Report

BALLARD MEDICAL PRODUCTS TRACH CARE PEDIATRIC "Y" TRACHEOBRONCHIAL SUCTION CATHETER   back to search results
Catalog Number 741
Event Date 02/01/2000
Event Type  Other   Patient Outcome  Other;
Event Description

A third party report stated that a customer informed the representative that a child did not get enough oxygen during ventilation. The alleged contributor was a broken secretion view port at the control valve bond of the catheter.

 
Manufacturer Narrative

Ballard medical conducted a comprehensive re-evaluation of complaint reports since october of 1999 to determine if additional mdr reporting was appropriate. The mdr being filed is subsequent to this re-evaluation. A broken secretion view port could cause a small leak in the ventilator circuit through the catheter tubing. The ventilator should alarm and compensate for leak. Break force is unusual.

 
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Brand NameTRACH CARE PEDIATRIC "Y"
Type of DeviceTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Brand NameTRACH CARE NEONATAL/PEDIATRIC "Y"
Baseline Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Catalogue Number741
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 pkwy
draper , UT 84020
(801) 523 -5105
Device Event Key327185
MDR Report Key337881
Event Key318034
Report Number1719891-2001-00032
Device Sequence Number1
Product CodeBSY
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/18/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/01/2004
Device Catalogue Number741
Device LOT Number65251
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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