BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE SYRINGE

    MDR report key: 8712171 · Received June 19, 2019

    Report

    Report Number
    1920898-2019-00551
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113653. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200750929, 200750887] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    MATERIAL NO.: 305950. BATCH NO.: 8113653. IT WAS REPORTED THAT BEFORE USE OF THE 1 ML ALLERGIST TRAY W/ BD SAFETYGLIDE¿ NEEDLE THE RUBBER PLUNGER DID NOT HAVE A GOOD SEAL AND THE MEDICATION "SQUIRTED BACK INTO THE BARREL OF THE SYRINGE". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER PLUNGER DID NOT HAVE A GOOD SEAL AND MEDICATION SQUIRTED BACK INTO BARREL OF SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 305950. BATCH NO.: 8113653. IT WAS REPORTED THAT BEFORE USE OF THE 1 ML ALLERGIST TRAY W/ BD SAFETYGLIDE¿ NEEDLE THE RUBBER PLUNGER DID NOT HAVE A GOOD SEAL AND THE MEDICATION "SQUIRTED BACK INTO THE BARREL OF THE SYRINGE". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER PLUNGER DID NOT HAVE A GOOD SEAL AND MEDICATION SQUIRTED BACK INTO BARREL OF SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508118 BD SAFETYGLIDE SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113653 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other