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Adverse Event Report

BALLARD MEDICAL PRODUCTS TRACH CARE 72 TRACHEOBRONCHIAL SUCTION CATHETER   back to search results
Catalog Number 227
Event Date 02/01/2003
Event Type  Malfunction  
Event Description

A report was received that during a suction procedure, the swivel of the closed suction system that attaches to the ventilator circuit broke off. No patient injury or adverse event were reported. Ballard medical products has no first hand knowledge of the allegations, but is relaying information received from outside sources pursuant to federal regulation.

 
Manufacturer Narrative

The male swivel and lock ring components were returned for evaluation, not the entire closed suction system. The evaluation was conducted prior to the components being sterilized. The investigation confirmed that, around the components, there were markings, cracks and marred. These findings were similar to what would happen if the components had been caught in the sub assembly machinery. The device history record was reviewed with no issues found during manufacture process. The manufacture process date was prior to internal corrective actions taken in the department. Those actions are: a dual valve dispenser and a vision sensor system were added to the assembly process; a 100% inspection in the sub assembly department was also implemented.

 
Search Alerts/Recalls

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Brand NameTRACH CARE 72
Type of DeviceTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Brand NameADULT TRACH CARE DOUBLE SWIVEL ELBOW PRODUCTS
Baseline Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Baseline Catalogue Number227
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 Key438998
MDR Report Key450002
Event Key426140
Report Number1719891-2003-00023
Device Sequence Number1
Product CodeBSY
Report Source Manufacturer
Source Type User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/24/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/01/2007
Device Catalogue Number227
Device LOT Number178988
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/19/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2002
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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