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Adverse Event Report

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

A report was received that during a suctioning procedure, the inside swivel connector came apart from the catheter. No adverse events, patient injury or medical intervention were reported. Ballard medical products has no first hand knowledge of the allegations, but is relaying information received from outside sources persuant to federal regulations.

 
Manufacturer Narrative

The lot number provided was not for this product family. The investigation confirmed the female lock ring (connector) was not glued onto the double swivel elbow subassembly of the catheter. Corrective actions have been initiated.

 
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Brand NameTRACH CARE
Type of DeviceTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Brand NameTRACH CARE
Baseline Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Catalogue Number2210IN
Baseline Device 510(K) Number
Baseline Device PMA Number
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 Key366582
MDR Report Key377517
Event Key356271
Report Number1719891-2002-00010
Device Sequence Number1
Product CodeBSY
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 01/16/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2210IN
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/22/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2002
Was Device Evaluated By Manufacturer? Yes
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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