BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14929245 · Received July 6, 2022

    Report

    Report Number
    1920898-2022-00426
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 20, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #:MEDICAL DEVICE LOT #: 0203534, EXPIRATION DATE: MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025, DEVICE MANUFACTURE DATE: 21-JUL-2020. LOT # MEDICAL DEVICE LOT #: UNKNOWN, EXPIRATION DATE MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (20) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THERE SEEMS TO BE SOMETHING IN SOME OF THE NEEDLES BLOCKING THE ADMINISTRATION AND PLUNGER STOPS. ALL RETURNED SYRINGES WERE EXAMINED AND TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. NO FOREIGN MATTER AND NO DEFECTS ON THE PLUNGER ROD WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0203534. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THAT THERE SEEMS TO BE SOMETHING IN SOME OF THE NEEDLES BLOCKING THE ADMINISTRATION AND PLUNGER STOPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS SOMETHING IN SOME OF THE NEEDLES BLOCKING THE ADMINISTRATION. PLUNGER STOPS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THAT THERE SEEMS TO BE SOMETHING IN SOME OF THE NEEDLES BLOCKING THE ADMINISTRATION AND PLUNGER STOPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS SOMETHING IN SOME OF THE NEEDLES BLOCKING THE ADMINISTRATION. PLUNGER STOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431264 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE 328438 2024620 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown