BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 16718089 · Received April 11, 2023

    Report

    Report Number
    1920898-2023-00215
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 25, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 26-APR-2023 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED THREE 1ML 30GA 8MM SYRINGES IN AN OPEN POLY BAG FROM LOT# 2031514. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE AND SHIELD WAS NOT SYRINGE IN THE BAG. CUSTOMER COULD NOT RE ATTACH THE NEEDLE SHIELD BECAUSE THREADING INSIDER THE SHIELD WAS DAMAGED. THE RETURNED SYRINGES WERE VISUALLY INSPECTED AND OBSERVED NO ISSUES WITH ANY KIND OF ISSUES THAT CUSTOMER REPORTED. THEREFORE, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2031514. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II INSULIN SYRINGE EXPERIENCED A NEEDLE BROKEN OFF OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLE AND NEEDLE SHIELD WAS NOT ON 1 SYRINGE IN THE BAG, (PARTS LOOSE IN BAG) STATED, HE DID NOT STICK HIMSELF WITH THE EXPOSED NEEDLE STATED, HE COULD NOT RE-ATTACH THE NEEDLE SHIELD BECAUSE THE THREADING INSIDE THE NEEDLE SHIELD, WAS DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II INSULIN SYRINGE EXPERIENCED A NEEDLE BROKEN OFF OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLE AND NEEDLE SHIELD WAS NOT ON 1 SYRINGE IN THE BAG, (PARTS LOOSE IN BAG). STATED, HE DID NOT STICK HIMSELF WITH THE EXPOSED NEEDLE. STATED, HE COULD NOT RE-ATTACH THE NEEDLE SHIELD BECAUSE THE THREADING INSIDE THE NEEDLE SHIELD, WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424949 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2031514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown