BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 12789895 · Received November 10, 2021

    Report

    Report Number
    1920898-2021-01175
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 11/11/2021 H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC, 8MM SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE SAME CONDITION AS SHOWN IN THE PHOTOS. CUSTOMER RETURNED IMAGES OF A SINGLE 0.3ML SYRINGE. THE BLACK RUBBER STOPPER AT THE DISTAL TIP OF THE PLUNGER IS WARPED ON ONE SIDE, LEAVING IT UNEVEN INSIDE THE BARREL OF THE SYRINGE. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. BASED ON THE IMAGES AND SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DAMAGE TO THE RUBBER STOPPER. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. INITIAL REPORTER PHONE# : (B)(6). INITIAL REPORTER FAX# : (B)(6). INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE MANUFACTURE DATE : UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE STOPPER WAS DEFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE STOPPER WAS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686802 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown