BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 17195568 · Received June 23, 2023

    Report

    Report Number
    1920898-2023-00385
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JUN-2023. H6: INVESTIGATION SUMMARY: THE CUSTOMER RETURNED (2) 0.5ML 8MM SYRINGES, REPORTING NEEDLE HUB SEPARATES. THE SYRINGES WERE VISUALLY INSPECTED AND OBSERVED CANNULA HUB SEPARATED FROM THE BARREL TIP ON (1) SYRINGE AND NO PHYSICAL DAMAGES OR ISSUES ON THE (2) SYRINGE. BASED ON THE SAMPLE RETURNED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #2063328. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER-INDICATED FAILURE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT 2 OF THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD THE NEEDLE AND HUBS SEPARATE. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE HUBS SEPARATED FROM 2 SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD THE NEEDLE AND HUBS SEPARATE. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE HUBS SEPARATED FROM 2 SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758168 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328290 2063328 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown