BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 6MM 90

    MDR report key: 12206743 · Received July 21, 2021

    Report

    Report Number
    1920898-2021-00800
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 23, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249084
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED A SINGLE 1ML SYRINGE. THE SYRINGE IS MISSING ITS NEEDLE SHIELD. THE NEEDLE HAS BECOME BENT AS A RESULT OF THE NEEDLE SHIELD MISSING. HOWEVER, NO DETERMINATIONS CAN BE MADE SINCE IT IS NOT KNOWN IF OR WHEN A NEEDLE SHIELD WAS PROPERLY APPLIED TO THE SYRINGE. ADDITIONALLY, THE NEEDLE SHIELD CANNOT BE EVALUATED AS A RESULT OF IT MISSING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0140383. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE SHIELD MISSING FROM THE SYRINGE. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 SYRINGE 1.0ML 6MM 90 HAD PRODUCT DAMAGED AND A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT ONE OF THE SYRINGES IN THE BAG WAS MISSING THE SHIELD, THE BAG WAS SEALED AND THE SHIELD WAS NOT IN THE BAG WITH THE NEEDLE ALSO EXPOSED. DATE OF EVENT : (B)(6) 2021. SAMPLES: AVAILABLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS PENDING 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 SYRINGE 1.0ML 6MM 90 HAD PRODUCT DAMAGED AND A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT ONE OF THE SYRINGES IN THE BAG WAS MISSING THE SHIELD, THE BAG WAS SEALED AND THE SHIELD WAS NOT IN THE BAG WITH THE NEEDLE ALSO EXPOSED. DATE OF EVENT : (B)(6) 2021. SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104059 SYRINGE 1.0ML 6MM 90 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324908 0140383 00382903249084

    Patients

    Seq Age Sex Outcome Treatment
    1