BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10963687 · Received December 7, 2020

    Report

    Report Number
    2243072-2020-02015
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 12, 2020
    Report Date
    March 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 2 PHOTOS OF (4) LOOSE 0.3ML BD INSULIN SYRINGES WERE PROVIDED. THE CUSTOMER REPORTED WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE BARREL. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT 2 OUT OF THE 4 SYRINGES EXHIBITED HUB SEPARATION. HUB SEPARATION WAS NOT OBSERVED ON THE OTHER 2 SYRINGES PICTURED. DUE TO BATCH NUMBER BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427937 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1