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Adverse Event Report

BALLARD MEDICAL PRODUCTS TRACH CARE TRACHEOBRONCHIAL SUCTION CATHETER   back to search results
Catalog Number 2210-4
Event Date 10/01/2002
Event Type  Malfunction  
Event Description

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

 
Manufacturer Narrative

The used product was returned without the female swivel and lock ring of the closed suction system. The evaluation confirmed that there was no solvent (bond) between the elbow manifold and double swivel elbow (connector). Since this lot was manufactured, a vision system has been implemented on the automated process and 100% inspection is conducted in the assembly process.

 
Search Alerts/Recalls

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Brand NameTRACH 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 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 Key416216
MDR Report Key427202
Event Key404131
Report Number1719891-2002-00091
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 Date01/01/2007
Device Catalogue Number2210-4
Device LOT Number164715
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 Manufactured02/01/2002
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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