BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE CATHETERS STRAIGHT

    MDR report key: 12023893 · Received June 18, 2021

    Report

    Report Number
    3011175548-2021-00669
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    November 14, 2020
    Report Date
    December 2, 2021
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    GBZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DETAILS OF THE COMPLAINT IT WAS REPORTED THAT THE CATHETER BROKE WHEN WHAT WAS DESCRIBED AS ROUTINE STRIPPING OF THE CATHETER WAS PERFORMED. AS THE CATHETER WAS NOT RETURNED AND NO LOT NUMBER PROVIDED THERE IS NO WAY TO CONFIRM THE COMPLAINT. AS THERE WAS NO LOT NUMBER OR OTHER DETAILS A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. AS PART OF THIS INCOMING INSPECTION, THE VENDOR CERTIFIES THAT THE PRODUCT MET THE TENSILE TEST REQUIREMENTS. THE TENSILE REQUIREMENT ARE THE FOLLOWING: UNPUNCHED CATHETER AVERAGE BRAKE FORCE IN (LB.) MIN = 15LBS. PUNCHED CATHETER AVERAGE BREAK FORCE (LB.) MIN =10LBS. MOLDED ADAPTER AVERAGE BREAK FORCE (LB.) MIN 15LB. BASED ON THE TENSILE REQUIREMENTS IT SUGGESTS THAT AN EXCESSIVE AMOUNT OF FORCE WAS USED DURING THE PROCESS OF STRIPPING THE CATHETER. AT A MINIMUM 10 LBS. OF FORCE WOULD HAVE NEEDED TO BE APPLIED. AS THE INCIDENT OCCURRED ON (B)(6) 2020, A SEARCH WAS CONDUCTED TO DETERMINE WHAT INCOMING INSPECTION RECORDS TO REVIEW. THE SEARCH RESULTED IN IDENTIFYING THREE LOTS RECEIVED AND INSPECTED PRIOR TO THE ON (B)(6) 2020 OCCURRENCE DATE. INCOMING INSPECTION WAS COMPLETED IN MAR 2020 AND PASSED ALL QUALITY REQUIREMENTS. THE SECOND INCOMING INSPECTION RECORD WAS CONDUCTED IN APR 2020 AND PASSED ALL QUALITY REQUIREMENTS. LASTLY INCOMING INSPECTION RECORD INSPECTED IN AUGUST 2020 ALSO PASSED ALL QUALITY REQUIREMENTS AT INCOMING INSPECTION. THERE IS NO MENTION AS TO THE LOCATION OF THE BREAKAGE OF THE CATHETER AND NO IMAGES PROVIDED. WITHOUT THIS KEY INFORMATION, A DETERMINATION OF ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION THAT THE PRODUCT DID NOT MEET ANY OF ITS REQUIREMENTS BASED ON PAST INCOMING INSPECTION RESULTS. H3 OTHER TEXT: NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CHEST TUBE BROKE DURING ROUTINE STRIPPING OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924419 SILICONE CATHETERS STRAIGHT CATHETER, CHOLANGIOGRAPHY GBZ ATRIUM MEDICAL CORPORATION 14016
    924420 SILICONE CATHETERS STRAIGHT CATHETER, CHOLANGIOGRAPHY GBZ ATRIUM MEDICAL CORPORATION 14016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown