BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60CC LL TIP CONVENIENCE PAK

    MDR report key: 8700761 · Received June 14, 2019

    Report

    Report Number
    9610847-2019-00416
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF OTHER / LEAKAGE PAST STOPPER FOR LOT #9021501 ITEM #309680. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE COLUMBUS BATCHES (8123780, 8123782) ASSOCIATED WITH THE NOGALES BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 60CC LL TIP CONVENIENCE PAK EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680, BATCH NO: 9021501. DETAILS OF COMPLAINT (REPORTED ISSUE): THERE WERE 2 DIFFERENT SITUATIONS WITH REGARDS TO THIS ITEM. ON THE FIRST SITUATION WHEN SYRINGE WAS FILLED WITH CHEMO MEDICATION THE PISTON STARTED MOVING UP CAUSING AN AIR BUBBLE IN THE SYRINGE. THE SECOND SITUATION THE PISTON STARTED MOVING DOWNWARDS CAUSING CHEMO MEDICATION TO SPILL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493687 SYRINGE 60CC LL TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9021501 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other