BEUDAMED
    FDA Adverse Event Other Summary report: N

    T-SAW

    MDR report key: 326440 · Received April 6, 2001

    Report

    Report Number
    1526439-2001-00008
    Event Type
    Other
    Date Received
    April 6, 2001
    Date of Event
    March 6, 2001
    Report Date
    April 6, 2001
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    HTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED RECEIVED A T-SAW CATHETER THAT WAS BROKEN INTO SEVERAL PIECES. ACCORDING TO THE COMPLAINTANT, THE CATHETER BROKEN WHEN THE T-SAW WAS INSERTED THROUGH THE CATHETER. THE SURGERY TIME WAS EXTENDED DUE TO THIS EVENT. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PT. A COMPLAINT HISTORY ANALYSIS WAS PERFORMED AND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PART NUMBER. EVALUATION OF THE RETURNED CATHETER REVEALED THAT THE PRODUCT WAS SEVERAL YEARS OLD. THE PRODUCT WAS STERILIZED VIA GAMMA IRRADIATION WHICH COULD, OVERTIME, CAUSE THE PLASTIC CATHETER TO BECOME BRITTLE. CURRENT CATHETERS ARE STERILIZED VIA ETHYLENE OXIDE (ETO) WHICH WILL NOT EFFECT THE MATERIAL PROPERTIES OF THE CATHETERS OVER TIME. ALL INVENTORY THAT WAS GAMMA STERILIZED HAS BEEN SCRAPPED. ALL DISTRIBUTORS SHOWN TO HAVE INVENTORY OF THE OLD T-SAW CATHETER WERE ASKED TO CHECK FOR GAMMA STERILIZED PRODUCT. ALL DISTRIBUTORS REPORTED THAT THE CATHETERS HAS BEEN RETURNED OR THAT THE CATHETERS WERE USED WITHOUT INCIDENT. NO CATHETERS WERE DISTRIBUTED DIRECTLY TO HOSPITALS. THIS IS THE ONLY REPORTED INCIDENT OF THIS TYPE. NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15270 T-SAW CATHETER HTZ DEPUY ACROMED, INC. NA RJ5PL1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other