BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE 29G

    MDR report key: 16246042 · Received January 26, 2023

    Report

    Report Number
    1920898-2023-00022
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 16, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266661
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 01-FEB-2023. H6: INVESTIGATION SUMMARY ; CUSTOMER RETURNED (1) LOOSE 0.5ML BD INSULIN SYRINGE WITH AN OPEN POLYBAG FROM LOT# 2052388. THE CUSTOMER REPORTED A DAMAGED AND BROKEN HUB. THE SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE BARREL TIP WAS BROKEN OFF AND LODGED INSIDE OF THE HUB ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2052388. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A DEFINITIVE ROOT-CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE 29G THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE HUB WAS FOUND TO BE CRACKED BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE 29G THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE HUB WAS FOUND TO BE CRACKED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823751 BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE 29G PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052388 00382903266661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown