BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14875586 · Received June 30, 2022

    Report

    Report Number
    1920898-2022-00423
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND ONE NON-CONFORMANCE WAS RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. THE REPORTED ISSUE WAS OBSERVED AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. INITIAL REPORTER NAME AND ADDRESS: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. MEDICAL DEVICE LOT #: 1242719, MEDICAL DEVICE EXPIRATION DATE: 2026-09-30, DEVICE MANUFACTURE DATE: 2021-08-30. MEDICAL DEVICE LOT #: 9343317, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2019-12-09.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE OF THE, BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE, THE PLUNGER RODS ARE DIFFICULT TO MOVE THROUGH THE BARREL OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 324910 BATCH NO. 1242719, 9343317. IT WAS REPORTED BY THE INVESTIGATORS THAT SYRINGES HAVE PLUNGERS SEPARATED FROM THEIR STOPPERS AND ALSO SOME SYRINGES HAVE PLUNGER RODS THAT ARE DIFFICULT TO MOVE THROUGH THE BARREL OF THE SYRINGE. VERBATIM: THE CUSTOMER HAS RETURNED THE SAMPLES FOR (B)(4). AMONG THE SYRINGE SAMPLES RETURNED, 3 HAVE PLUNGERS THAT HAVE SEPARATED FROM THEIR STOPPERS. IT WAS ALSO NOTED THAT 20 OTHER SYRINGES HAVE PLUNGER RODS THAT ARE DIFFICULT TO MOVE THROUGH THE BARREL OF THE SYRINGE. A NEW COMPLAINT WILL NEED TO BE OPENED TO COVER THESE INCIDENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015500 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9343317 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown