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Adverse Event Report

BALLARD MEDICAL PRODUCTS TRACH TRACH CARE TRACHEOBRONCHIAL SUCTION CATHETER   back to search results
Catalog Number 2210-4
Event Date 07/01/2002
Event Type  Malfunction  
Event Description

A report was rec'd that during a suctioning procedure, the swivel connector on the circuit end fell apart. No pt injury or adverse event were reported. Ballard medical products has no first hand knowledge of the allegations, but is relaying info rec'd from outside sources pursuant to federal regulations.

 
Manufacturer Narrative

The device has not been returned for eval. The distributor cited two potential lot numbers that may be attributed to the device. The product will not be returned for eval. Without product for eval or a confirmed actual lot number, at this time, a conclusion cannot be drawn relative to the alleged device failure.

 
Search Alerts/Recalls

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Brand NameTRACH TRACH CARE
Type of DeviceTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Brand NameADULT TRACH CARE DOUBLE SWIVEL ELBOW
Baseline Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Catalogue Number2210-4
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 parkway
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
12050 lone peak parkway
draper UT 84020
Manufacturer Contact
sally herrick
12050 lone peak parkway
draper , UT 84020
(801) 523 -5105
Device Event Key402065
MDR Report Key413013
Event Key390541
Report Number1719891-2002-00053
Device Sequence Number1
Product CodeBSY
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/29/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2210-4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/29/2002
Was Device Evaluated By Manufacturer? No
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 February 28, 2009

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