BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 9035264 · Received September 13, 2019

    Report

    Report Number
    9616656-2019-00861
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    July 19, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 5MM, 30G AUTOSHIELD DUO SAMPLES FROM LOT # 8241657. CUSTOMER STATES THAT APPLYING THE DRUG, THE NEEDLE ENTERS THE SKIN AND EVEN BLEEDS, BUT THE DRUG IS NOT APPLIED AND IT GETS ALL IN THE NEEDLE. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE AUTOSHIELD DUO SAMPLES TO BE PROPERLY ACTIVATED WITHOUT ANY OBSERVED DEFECTS. PHOTOS OF THE INJECTION SITES WERE ALSO PROVIDED. WITHOUT THE PHYSICAL SAMPLES, IT IS DIFFICULT TO DETERMINE IF THERE IS A POTENTIAL NEEDLE POINT INTEGRITY ISSUE, A CLOGGED NEEDLE ISSUE, OR A DIFFICULT TO OPERATE ISSUE SOLELY FROM THE ATTACHED PHOTOS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS IT IS DIFFICULT TO DETERMINE IF THERE IS A POTENTIAL NEEDLE POINT INTEGRITY ISSUE, A CLOGGED NEEDLE ISSUE, OR A DIFFICULT TO OPERATE ISSUE SOLELY FROM THE ATTACHED PHOTOS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE FAILED TO DELIVER MEDICATION AFTER BEING INSERTING INTO THE PATIENT'S SKIN. THE MEDICATION REPORTEDLY GOT STUCK IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "COMPLAINANT REPORTED THAT WHEN APPLYING THE DRUG, THE NEEDLE ENTERS THE SKIN AND EVEN BLEEDS, BUT THE DRUG IS NOT APPLIED. SHE SAID IT GETS ALL IN THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826507 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8241657

    Patients

    Seq Age Sex Outcome Treatment
    1 Other