BEUDAMED
    FDA Adverse Event Other Summary report: N

    IRRIGATION CATHETER, 4F, 80CM

    MDR report key: 1022521 · Received March 24, 2008

    Report

    Report Number
    2027111-2008-00011
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    March 5, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GBX
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: INSPECTION OF THE RETURNED CATHETER DID NOT REVEAL ANY DAMAGE. CATHETER PASSED A VISUAL INSPECTION AND A CATHETER/HUB LEAK TEST. A LEAK TEST WAS DONE BY PLACING AN IRIS VALVE OVER THE TIP OF THE CATHETER AND A 10CC SYRINGE WAS USED TO INFLATE THE CATHETER THROUGH THE HUB. THE HUB AND CATHETER WAS SUBMERGED UNDER WATER IN ITS PRESSURIZED CONDITION FOR DURATION OF 20 SECONDS. NO AIR BUBBLES WERE OBSERVED OR ESCAPED TO THE SURFACE. IT IS UNCLEAR WHAT THE CUSTOMER MEANS BY "CATHETER BROKEN @ HUB". NONE OF THE ABOVE LOT REMAINS IN FINISHED GOOD. CONCLUSION/CORRECTIVE ACTION: ALL CATHETERS UNDERGO A 100% VISUAL INSPECTION AND LEAK TEST/HUB PULL FORCE DURING PRODUCTION AT SUB ASSEMBLY LEVEL. IN ADDITION TO THIS TESTING, AN AQL SAMPLE IS TAKEN FROM EACH SHOP ORDER BY QC, THEN VISUALLY INSPECTED, LEAK AND PULL TESTED PRIOR TO STERILIZATION. ALL CATHETERS SAMPLED MUST REACH THE MINIMUM SPECIFICATION PULL FORCE PRIOR TO FAILURE. S/O 1031363 WAS REVIEWED AND HAS NO DEVIATION. ALL SAMPLES PASSED SPECIFICATION LISTED IN THE MI, QI AND DRAWING. PIDS SPECIFY THE INSTRUCTIONS FOR USE. DUE TO THE FACT THAT S/O 1031363 PASSED ALL REGULAR MANUFACTURING AND QC INSPECTION AND UNCLEAR INFORMATION HOW THIS CATHETER WAS USED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "CATHETER BROKEN @ HUB -LEAKED DYE MULTIPLE TIMES. NEEDED TO REMOVE CATHETER, WAIT FOR NEW ONE TO BE FOUND AND RE-INSERTED INTO CYSTO DUCT A 2ND TIME." PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRRIGATION CATHETER, 4F, 80CM IRRIGATION CATHETER GBX APPLIED MEDICAL RESOURCES IRR-080-4F 1031363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other