BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 8MM 90 BX 450 MO

    MDR report key: 9708210 · Received February 13, 2020

    Report

    Report Number
    1920898-2020-00127
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 23, 2020
    Report Date
    March 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) 1CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 9063823. CUSTOMER STATES THAT THERE WAS LEAKAGE, A BENT NEEDLE, AND DID NOT GET THE DOSAGE. BOTH RETURNED SAMPLES WERE EXAMINED AND NO BENT CANNULA WAS OBSERVED. HOWEVER, ONE SAMPLE EXHIBITED A DEFORMED STOPPER IN THE BARREL. THE REMAINING SYRINGE EXHIBITED ADHESIVE SPLATTER ON THE OUTER SURFACE OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812920] NOTED FOR CRACKED BARREL. THERE WAS ONE (1) NOTIFICATION [200812809] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED STOPPER AND ADHESIVE SPLATTER ON BARREL). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA). WHEN THE PLUNGER/STOPPER WAS EXERCISED, THERE WAS RESISTANCE INDICATING INSUFFICIENT SILICONE. MAINTENANCE DISPATCH 61496 WAS GENERATED DURING THE PRODUCTION OF THIS BATCH FOR DRY BARRELS. THE ISSUE WAS RESOLVED BY REPLACING THE NOZZLE ON THE SILICONE GUN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A SYRINGE 1.0ML 8MM 90 BX 450 MO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE FROM ONE SYRINGE STATED, DID NOT GET DOSAGE, HAD TO USE A SECOND SYRINGE STATED, FINDING ANOTHER SYRINGE WITH BENT NEEDLE PRIOR TO INJECTION, COULD NOT USE." 3 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 LEAKAGE OCCURRED DURING USE WITH A SYRINGE 1.0ML 8MM 90 BX 450 MO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE FROM ONE SYRINGE STATED, DID NOT GET DOSAGE, HAD TO USE A SECOND SYRINGE STATED, FINDING ANOTHER SYRINGE WITH BENT NEEDLE PRIOR TO INJECTION, COULD NOT USE." 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172961 SYRINGE 1.0ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328289 9063823 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other