BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 14159724 · Received April 20, 2022

    Report

    Report Number
    1920898-2022-00254
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 18, 2022
    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

    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

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 0.3ML SYRINGES. THERE WERE NO IMMEDIATELY OBSERVABLE DEFECTS TO EITHER SYRINGE. ONLY MINIMAL, INCONSEQUENTIAL IMPERFECTIONS WERE OBSERVED UNDER MAGNIFICATION. BOTH SAMPLES RECEIVED SHIELD PULL FORCE TESTING. THE AMOUNT OF FORCE REQUIRED TO REMOVE THE NEEDLE SHIELD FOR THESE SAMPLES WERE 3.58 LBS AND 3.42 LBS. THE SPECIFICATION STATES THAT ALL PULL FORCES WITHIN THE RANGE OF 0.85 LBS TO 5.95 LBS ARE ACCEPTABLE. NEITHER OF THE SAMPLES TESTED OUTSIDE OF THE REQUIRED RANGE AND NEITHER OF THE SAMPLES DISASSEMBLED DURING TESTING. BOTH SAMPLES RETURNED DO NOT FEATURE ANY DEFECTS AND FUNCTION AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1123341. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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¿ 3/10ML INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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
    2584359 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown