BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"

    MDR report key: 16211024 · Received January 19, 2023

    Report

    Report Number
    1920898-2023-00010
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 30, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266319
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 20-JAN-2023. H6: INVESTIGATION SUMMARY; CUSTOMER RETURNED (1) LOOSE 3/10CC, 12.7MM SYRINGE. CUSTOMER STATES THAT THE STOPPER WAS DAMAGED/DEFECTIVE. THE RETURNED SYRINGE WAS EXAMINED AND NO DEFECTS WERE OBSERVED ON THE RETURNED SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2052357 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE STOPPER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE DISTRIBUTOR REPORTED THAT THE STOPPER WAS DAMAGED/DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE STOPPER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE DISTRIBUTOR REPORTED THAT THE STOPPER WAS DAMAGED/DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406869 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052357 00382903266319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown