BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13523848 · Received February 14, 2022

    Report

    Report Number
    1920898-2022-00098
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 9, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-22. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 7 SYRINGES IN A POUCH LABELED FOR 0.5ML, 31 GAUGE, 8MM SYRINGES FROM LOT 1102549. THE SYRINGES HAVE ALL HAD THEIR NEEDLE SHIELDS AND HUBS SEPARATE FROM THE BARRELS. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. ADDITIONALLY, THE CONNECTORS AT THE DISTAL TIP OF THE BARRELS HAVE ALL BROKEN OFF AND ARE LIKEWISE STUCK IN THE NEEDLE SHIELD WITH THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1102549. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE FOR HUB SEPARATES (NEEDLE ASSEMBLY SEPARATE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : IT WAS REPORTED THAT THE NEEDLES DETACHED OR SEPARATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES DETACHED OR SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119848 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1102549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown