BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE ULTRA-FINE® 1ML 29G X 1/2"

    MDR report key: 15576838 · Received October 11, 2022

    Report

    Report Number
    1920898-2022-00705
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    August 28, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: 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

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060759. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE ULTRA-FINE® 1ML 29G X 1/2" EXPERIENCED NEEDLE THROUGHT SHIELD AFTER RECAPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2022 , THE PATIENT WAS INJECTED WITH BIOSYNTHETIC INSULIN, AND THE TREATMENT CARTRIDGE AND INSULIN WERE BROUGHT TO THE PATIENT FOR INJECTION. AFTER THE INJECTION, THE STAFF PUT THE CAP BACK INTO THE SYRINGE. HOWEVER, IT WAS FOUND THAT THE NEEDLE PIERCED THE NEEDLE CAP. THE MATERIAL OF THE NEEDLE CAP WAS SUSPECTED TO BE TOO SOFT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE ULTRA-FINE® 1ML 29G X 1/2" EXPERIENCED NEEDLE THROUGHT SHIELD AFTER RECAPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6). THE PATIENT WAS INJECTED WITH BIOSYNTHETIC INSULIN, AND THE TREATMENT CARTRIDGE AND INSULIN WERE BROUGHT TO THE PATIENT FOR INJECTION. AFTER THE INJECTION, THE STAFF PUT THE CAP BACK INTO THE SYRINGE. HOWEVER, IT WAS FOUND THAT THE NEEDLE PIERCED THE NEEDLE CAP. THE MATERIAL OF THE NEEDLE CAP WAS SUSPECTED TO BE TOO SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2911271 BD INSULIN SYRINGE ULTRA-FINE® 1ML 29G X 1/2" HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 1060759

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown