BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD U-F II 1CC 31G INSULIN SYRINGE

    MDR report key: 1161674 · Received September 15, 2008

    Report

    Report Number
    1920898-2008-00022
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ISSUE: NEEDLE BREAK-OFF. REGULATORY COMPLIANCE RECEIVED 2 SEALED POLYBAGS FROM LOT #8021489 EACH CONTAINING TEN (10) 1CC, BD U-F II, 31G SHORT SYRINGES. THE CUSTOMER CLAIMS THAT A NEEDLE BROKE OFF DURING INJECTION. THREE OUT OF THE 10 SYRINGES FROM EACH POLYBAG WERE RANDOMLY SELECTED AND EVALUATED FOR THE CUSTOMER'S COMPLAINT. THIS CONSISTS OF TESTING FOR POINT DAMAGE, LUBRICATION, AND MEASURING THE CANNULA OD. SIX OUT OF 6 SYRINGES EXHIBITED NO POINT DAMAGE, AND NO ISSUES WERE OBSERVED ALONG THE LENGTH OF THE CANNULA; THEY WERE FOUND TO BE AMPLY LUBED AND MET SPECS FOR CANNULA OD FOR THE 31G CANNULA [SPEC 0.0100 - 0.0105; DATA: 0.0101, 0.0102, 0.0104, 0.0102, 0.0102, 0.0103]. USING LUXO-MAGNIFIER UV LAMP THE 6 SYRINGES EXHIBITED SUFFICIENT EPOXY TO HOLD THE CANNULA IN PLACE. NO DEFECTS WERE FOUND OR NOTED WITH THE RETURNED PRODUCT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. THERE WERE NO OBVIOUS TRENDS OBSERVED. A DEVICE HISTORY REVIEW WAS ALSO CONDUCTED AND NO ANOMALIES WERE NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTS NEEDLE BREAK-OFF IN STOMACH. SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM BUT ATTENDANTS COULD NOT GET THE NEEDLE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD U-F II 1CC 31G INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA 8021489

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R