BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 13541687 · Received February 16, 2022

    Report

    Report Number
    1920898-2022-00107
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 4, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-23. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF 34 SYRINGES ACROSS 5 POLYBAGS FOR 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1123341. ONE POLYBAG HAD BEEN OPENED. EACH OF THE SYRINGES RETURNED WERE INSPECTED, WITH ONE SYRINGE VISIBLY SHOWING THE RUBBER STOPPER DRAGGING INSIDE THE BARREL. THE REST WERE TESTED FOR FUNCTIONALITY. ANOTHER SYRINGE IN A PREVIOUSLY UNOPENED POLYBAG WAS FOUND TO DRAG SIGNIFICANTLY INSIDE THE SYRINGE BARREL, THOUGH IT DID NOT SHOW IT VISIBLY. THE REMAINING SAMPLES ALL FUNCTIONED 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, BD FOUND THAT ONE SYRINGE HAD A VISIBLE DEFECT IN ITS RUBBER STOPPER AND ONE SYRINGE WAS DRAGGING INSIDE THE BARREL. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED A DEFORMED STOPPER AND DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STOPPER WAS SKEWED IN THE BARREL, WHICH MADE IT DIFFICULT FOR THE USER TO MEASURE THE VOLUME CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE EXPERIENCED A DEFORMED STOPPER AND DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STOPPER WAS SKEWED IN THE BARREL, WHICH MADE IT DIFFICULT FOR THE USER TO MEASURE THE VOLUME CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6048 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown