BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10987992 · Received December 10, 2020

    Report

    Report Number
    2243072-2020-02037
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 17, 2020
    Report Date
    January 15, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 12/17/2020 H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT WHEN REMOVING THE ORANGE-COLORED SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL. THE RETURNED SYRINGE WAS TESTED AND THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL WHEN ATTEMPTING TO REMOVE THE SHIELD. UNABLE TO PERFORM DHR CHECK FOR NEEDLE HUB SEPARATES DUE TO UNKNOWN LOT NUMBER. ROOT CAUSE: 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 ORANGE-COLORED SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ORANGE-COLORED SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452495 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1