BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 16030199 · Received December 21, 2022

    Report

    Report Number
    1920898-2022-00900
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 5, 2022
    Report Date
    May 16, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 2052357, D4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2027, H4. DEVICE MANUFACTURE DATE: 21FEB2022. D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 11JAN2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED ILLEGIBLE PACKAGING INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH A PRINTING DEFECT ON THE SHELF CARTON, THE PRODUCT INFORMATION IS ILLEGIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED ILLEGIBLE PACKAGING INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH A PRINTING DEFECT ON THE SHELF CARTON, THE PRODUCT INFORMATION IS ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859069 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 2052357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown