BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

    MDR report key: 9880601 · Received March 25, 2020

    Report

    Report Number
    1920898-2020-00309
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 16, 2020
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/26/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (100) 29GX12.7MM, 1ML BD INSULIN SYRINGES IN SEALED BLISTER PACKS FROM LOT 9140524. CONSUMER REPORTED NEEDLE WAS STICKING THOUGH ORANGE CAP AND WHEN HEALTH WORKER PICKED IT UP THEY RECEIVED A NEEDLE STICK INJURY. ALL 100 RETURNED SYRINGES WERE EXAMINED, AND ONE WAS OBSERVED WITH A CANNULA PIERCED THROUGH THE CANNULA SHIELD; THIS SYRINGE WAS INSIDE OF A SEALED BLISTER PACK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140524. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS SUMMARY: THIS OPERATION ASSEMBLES THE CANNULA INTO THE BARREL TIP AND APPLIES ADHESIVE TO HOLD THE CANNULA IN THE BARREL TIP. THE RACKS OF CANNULATED BARRELS THEN TRAVEL THROUGH AN OVEN WHICH USES IR LIGHT TO FACILITATE ADHESIVE RUN DOWN AND ULTRAVIOLET LIGHT TO CURE THE ADHESIVE THAT BONDS THE CANNULA TO THE BARREL TIP. THE CANNULATED BARRELS ARE THEN CONVEYED TO A MACHINE THAT INSPECTS FOR MISSING CANNULA, CANNULA HEIGHT, POINT QUALITY, ZERO LINE PLACEMENT, AND UV ADHESIVE. IT ALSO SUPPLIES LUBE TO THE CANNULA, FEATURES TWO LUMEN BLOWS, ASSEMBLES THE SHIELD TO THE BARREL/CANNULA ASSEMBLY, AND DETECTS FOR MISSING SHIELDS. THE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES RELATING TO THIS COMPLAINT DURING THE PRODUCTION OF THIS BATCH. A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WAS STICKING THOUGH ORANGE CAP AND WHEN HEALTH WORKER PICKED IT UP THEY RECEIVED A NEEDLE STICK INJURY. NEEDLE WAS STICKING THOUGH ORANGE CAP AND THE BLISTER PACK OF THE SYRINGE AND WHEN HEALTH WORKER PICKED IT UP THEY RECEIVED A NEEDLE STICK INJURY.

    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 THAT THE SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WAS STICKING THOUGH ORANGE CAP AND WHEN HEALTH WORKER PICKED IT UP THEY RECEIVED A NEEDLE STICK INJURY. NEEDLE WAS STICKING THOUGH ORANGE CAP AND THE BLISTER PACK OF THE SYRINGE AND WHEN HEALTH WORKER PICKED IT UP THEY RECEIVED A NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345092 SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU SYRINGE FMF BD MEDICAL - DIABETES CARE 9140524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other