BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM

    MDR report key: 12277492 · Received August 4, 2021

    Report

    Report Number
    1920898-2021-00852
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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: 7/27/2021 H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE 1ML SYRINGE WITH NO OTHER IDENTIFICATION. THE INTEGRATED NEEDLE HUB HAD PARTIALLY BROKEN AWAY FROM THE BARREL OF THE SYRINGE AT THE HUB¿S BASE. THE SPLIT STARTS AT ONE SIDE OF THE BASE AND STRETCHES ACROSS THE TRANSVERSE PLANE, APPROXIMATELY 2/3RDS OF THE DISTANCE THROUGH THE BASE, RESULTING IN THE SEPARATED PORTION STICKING OUT AT AN ANGLE FROM THE REST OF THE SYRINGE. THIS DAMAGE MAY HAVE HAPPENED AS THE RESULT OF HIGH STRESSES PLACED ACROSS THE NEEDLE HUB. THERE DID NOT APPEAR TO BE ANY OTHER DAMAGE TO THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1011823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SYRINGE¿S NEEDLE BENDING. THE ROOT CAUSE OF THE BARREL TIP BREAKING APPEARS TO BE HIGH STRESSES PLACED ACROSS THE BARREL AND NEEDLE HUB. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 1.0ML 31GA 8MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT 1 SYRINGE NEEDLE HUB WAS BROKEN OFF IN SHIELD. OCCURED DATE : UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER CITY AND STATE : (B)(6). 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 1 BD SYRINGE 1.0ML 31GA 8MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT 1 SYRINGE NEEDLE HUB WAS BROKEN OFF IN SHIELD. OCCURED DATE : UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172386 SYRINGE 1.0ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1011823

    Patients

    Seq Age Sex Outcome Treatment
    1