BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15525233 · Received October 1, 2022

    Report

    Report Number
    1920898-2022-00668
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 12, 2022
    Report Date
    November 11, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466011
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER E-MAIL: UNKNOWN. 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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-SEP-2022 INVESTIGATION SUMMARY CUSTOMER RETURNED (1) LOOSE 0.5ML BD INSULIN SYRINGE. THE CUSTOMER REPORTED THAT WHEN THE NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB WAS MISSING AND MIGHT BE IN THE NEEDLE SHIELD. THE SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240944. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTION ¿ CAPA HAS BEEN COMPLETED WHICH ADDRESSES THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD ISSUES WITH THEIR HUBS SEPARATING AFTER REMOVING THE NEEDLE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND SEVERAL WHEN REMOVED NEEDLE SHIELD, THE NEEDLE HUB WAS MISSING. FEELS IT MIGHT BE IN THE NEEDLE SHIELD. SAVED ONE EXAMPLE FROM TODAY (B)(6) 2022 INCIDENT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD ISSUES WITH THEIR HUBS SEPARATING AFTER REMOVING THE NEEDLE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND SEVERAL WHEN REMOVED NEEDLE SHIELD, THE NEEDLE HUB WAS MISSING. FEELS IT MIGHT BE IN THE NEEDLE SHIELD. SAVED ONE EXAMPLE FROM TODAY 09-12-2022 INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171717 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7240944 00382908466011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown