BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 17234720 · Received June 29, 2023

    Report

    Report Number
    3002682307-2023-00176
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. 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.

    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-JUL-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300600 AND LOT NUMBER 221111. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED NEEDLE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, A NEEDLE WAS A DAMAGED CANNULA POINT WAS OBSERVED AND A MARK IN THE SHIELD WHICH INDICATED A CANNULA PUNCTURE WAS ALSO OBSERVED. BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND THAT THIS ISSUE WAS RELATED TO THE HANDLING OF THE PRODUCT. ONCE THE SHIELD HAS BEEN REMOVED, ANY REASSEMBLY OF THE SHIELD (A PRACTICE NOT RECOMMENDED) WOULD NEED TO BE DONE CAREFULLY TO PREVENT ANY RISK OF DAMAGE TO THE CANNULA POINT, WHICH COULD THEN PROVOKE DISCOMFORT AT THE MOMENT OF INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE NEEDLE PENETRATED THE CAP. THE FOLLOWING WAS TRANLSATED FROM FRENCH TO ENGLISH: THIS MORNING WE HAD AN INCIDENT IN THE ONCOLOGY DEPARTMENT INVOLVING A HYPODERMIC NEEDLE REF 300600, BATCH 221111. THE NURSE TOOK ATROPINE FROM AN AMPOULE AND THEN PUT THE CAP BACK ON. THE FAULTY NEEDLE GOT STUCK IN THE CAP AND PROTRUDED THROUGH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE NEEDLE PENETRATED THE CAP. THE FOLLOWING WAS TRANLSATED FROM FRENCH TO ENGLISH: THIS MORNING WE HAD AN INCIDENT IN THE ONCOLOGY DEPARTMENT INVOLVING A HYPODERMIC NEEDLE REF 300600, BATCH 221111. THE NURSE TOOK ATROPINE FROM AN AMPOULE AND THEN PUT THE CAP BACK ON. THE FAULTY NEEDLE GOT STUCK IN THE CAP AND PROTRUDED THROUGH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823527 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 221111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown