BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE

    MDR report key: 12712915 · Received October 28, 2021

    Report

    Report Number
    3002682307-2021-00579
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 210540. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES CONSISTED OF FOUR STRIPS OF BLISTER PACKAGES CONTAINING FIVE NEEDLES EACH. THE PRODUCTS WERE EXAMINED AND NO DEFECTS RELATED TO THE PACKAGING COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BLUNT FILL NEEDLE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A NEW COMPLAINT WHERE PERFORATIONS ARE CONSTANTLY MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #:(B)(6). 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 · 1

    IT WAS REPORTED THAT THE BD BLUNT FILL NEEDLE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A NEW COMPLAINT WHERE PERFORATIONS ARE CONSTANTLY MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610014 BD BLUNT FILL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 210540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown