BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 17454958 · Received August 3, 2023

    Report

    Report Number
    1920898-2023-00518
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 28, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    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

    E.1. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2269224. D4. MEDICAL DEVICE EXPIRATION DATE 31OCT2027. H4. DEVICE MANUFACTURE DATE: 26SEP2022. D4. MEDICAL DEVICE LOT #: 2122331. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE: 02MAY2022. H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER 2269224 AND THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER 2122331. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THESE LOTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERELION INSULIN SYRINGE HAVE LIQUID COMING OUT OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER FINDING MORE SYRINGES WITH LIQUID COMING OUT OF NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284840 RELION INSULIN SYRINGE PISTON SYRINGEJAVASCRIPT:TABCLICKED(5) FMF BD MEDICAL - DIABETES CARE SEE H.10 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown