BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE

    MDR report key: 16524789 · Received March 10, 2023

    Report

    Report Number
    1920898-2023-00110
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 23-MAR-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE 0.3 ML SYRINGE INSIDE A SMALL ZIPPER BAG. IT WAS REPORTED FROM THE CUSTOMER THAT THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL WHEN THE SHIELD WAS REMOVED. THE RETURNED SYRINGE WAS VISUALLY INSPECTED, AND NO ISSUES WERE FOUND. THE HUB AND THE SHIELD WERE ATTACHED PROPERLY. THE SHIELED THEN WAS REMOVED AND ATTACHED MORE THAN 10 TIMES AND DID NOT CAUSE ANY HUB SEPARATION. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. SINCE THE ISSUE IS NOT CONFIRMED, THE ROOT CAUSE CAN NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT NEEDLE/SHIED SEPARATION. ACCORDING TO THE CUSTOMER'S REPORT, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL WHEN THE SHIELD WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT NEEDLE/SHIED SEPARATION. ACCORDING TO THE CUSTOMER'S REPORT, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL WHEN THE SHIELD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181398 BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown