BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES BLT FILL NC TW SHLD

    MDR report key: 19548470 · Received June 17, 2024

    Report

    Report Number
    3002682307-2024-00137
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 240109. 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, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A HAIR WAS IDENTIFIED WITHIN THE NEEDLE¿S BLISTER PACKAGING. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A TEMPORARY FAILURE IN GOOD MANUFACTURING PRACTICES. THIS IS A VERY UNUSUAL INCIDENT AS BD MAINTAINS STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS TO KEEP FOREIGN MATTER TO EXTREMELY LOW LEVELS. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE STRICT MEASURES ARE IN PLACE, INCLUDING CONTINUOUSLY FILTERED AIR, HIGHER PAIR PRESSURE IN THE CONTROLLED AREA THAN THE SURROUNDINGS, DOUBLE DOOR ACCESS, RESTRICTED ACCESS TO PERSONNEL, THE USE OF SPECIAL MANDATORY CLOTHING, AND ROUTINE TRAINING COURSES ON GOOD MANUFACTURING PRACTICES. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. THE MANUFACTURING PERSONNEL WERE ALERTED OF YOUR EXPERIENCE FOR FURTHER AWARENESS ON THE PRODUCTION FLOOR. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES BLT FILL NC TW SHLD HAIR FOUND IN THE PACKAGE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM DUTCH TO ENGLISH: I HEREBY REPORT A COMPLAINT, A HAIR WAS FOUND IN A PACKAGE. THE NEEDLE IS STILL PRESENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322726 BD CONVENTIONAL NEEDLES BLT FILL NC TW SHLD NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240109 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown