BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PLUS PEN NEEDLES 31G X 5MM (100 COUNT)

    MDR report key: 16792279 · Received April 21, 2023

    Report

    Report Number
    9616656-2023-00399
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    March 30, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: 04-MAY-2023. H6: INVESTIGATION SUMMARY A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ONE OPEN 31G X 5 MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 2061182, CAT. NO. 320518. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BROKEN PATIENT END OF CANNULA WAS OBSERVED. NO SHIELD WAS RETURNED, AND NO MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE SAMPLE. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3: 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 MICRO-FINE¿ PLUS PEN NEEDLES 31G X 5MM (100 COUNT) CANNULA INJECTOR BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: CUSTOMER COMPLAINS ABOUT PRODUCT - NEEDLE FOR INJECTOR BROKEN; LOT NO. 2061182 NEEDLES FOR INJECTORS 5 MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PLUS PEN NEEDLES 31G X 5MM (100 COUNT) CANNULA INJECTOR BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: CUSTOMER COMPLAINS ABOUT PRODUCT - NEEDLE FOR INJECTOR BROKEN. LOT NO. 2061182 NEEDLES FOR INJECTORS 5 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792236 BD MICRO-FINE¿ PLUS PEN NEEDLES 31G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2061182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown