BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    MDR report key: 8488176 · Received April 5, 2019

    Report

    Report Number
    1920898-2019-00322
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 20, 2019
    Report Date
    June 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED PHOTOS OF A 1/2CC, 12.7MM, 29G SYRINGE WITH THE BLISTER PACK FROM LOT # 7240991. CUSTOMER STATES THAT THE BARREL IS DESTROYED. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED CRACKS IN THE BARREL RANGING FROM THE 0-15 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240991. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200720172, 200720171, 200706852] NOTED FOR DAMAGED BARREL. THERE WERE TWO (2) NOTIFICATIONS [200705296, 200704761] NOTED FOR DAMAGED TIPS. THERE WERE TEN (10) NOTIFICATIONS [200719948, 200720205, 200720038, 200720172, 200719960, 200719959, 200720006, 200704761, 200706359, 200706592] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. POSSIBLE ROOT CAUSES: DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION; INFEED DIAL AT BARREL PRINTERS; LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX BARREL WAS FOUND DAMAGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE SYRINGE BARREL ARE DESTROYED".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX BARREL WAS FOUND DAMAGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE SYRINGE BARREL ARE DESTROYED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282082 SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7240991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other