BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13157915 · Received January 4, 2022

    Report

    Report Number
    1920898-2021-01360
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 6, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT ONE OF THE SYRINGES WHEN THE SHIELD WAS FINALLY REMOVED THE HUB ASSEMBLY WENT WITH IT. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-06. H6: INVESTIGATION SUMMARY : CUSTOMER RETURNED (1) LOOSE 0.5ML BD INSULIN SYRINGE. THE CONSUMER REPORTED THAT ONE OF THE SYRINGES WHEN THE SHIELD WAS FINALLY REMOVED THE HUB ASSEMBLY WENT WITH IT. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS PROPERLY ATTACHED TO THE BARREL. NO HUB SEPARATION WAS OBSERVED UPON SHIELD REMOVAL. NO DEFECTS WERE OBSERVED ON THE TESTED SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1172372. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT ONE OF THE SYRINGES WHEN THE SHIELD WAS FINALLY REMOVED THE HUB ASSEMBLY WENT WITH IT. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT FROM THIS BOX WITH ABOUT 6 TO 8 SYRINGES IT WAS DIFFICULT TO REMOVE THE NEEDLE SHIELDS AND THAT ONE THESE 6 SYRINGES WHEN FINALLY REMOVED THE SHIELD THE HUB ASSEMBLY WENT WITH IT. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480503 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1172372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown