BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20567346 · Received October 30, 2024

    Report

    Report Number
    3002682307-2024-00229
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 2, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903102051
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 310205 AND LOT NUMBER: 240320. 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, TWO (2) PICTURES AND ONE (1) PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, A HAIR WAS OBSERVED, CONFIRMING THE REPORTED DEFECT. HOWEVER, THE PHYSICAL SAMPLE DID NOT SHOW ANY HAIR. IT IS POSSIBLE THAT THE HAIR BECAME LOOSE AT SOME POINT DURING SHIPMENT AND TRANSPORTATION. IT IS MOST LIKELY THAT THIS INCIDENT RESULTED FROM A FAILURE IN GOOD MANUFACTURING PRACTICES (GMP). HOWEVER, THIS IS A VERY UNUSUAL INCIDENT AS BD KEEPS FOREIGN MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE FOLLOWED. AIR IS CONTINUOUSLY FILTERED, AIR PRESSURE IS HIGHER IN CONTROLLED AREAS TO REDUCE CONTAMINATION, DOUBLE DOORS ARE USED TO ACCESS THE ROOM, ACCESS IS RESTRICTED, SPECIAL CLOTHES ARE MANDATORY FOR THOSE WHO ENTER, AND PERSONNEL RECEIVE ROUTINE TRAINING COURSES ON GMPS. WE WOULD ALSO LIKE TO INFORM YOU THAT IN NOVEMBER 2024 (AFTER THE AFFECTED NEEDLE WAS MANUFACTURED) A NEW HAIR PROTECTION PROCESS WAS IMPLEMENTED, TO HELP REDUCE THIS POTENTIAL DEFECT FROM OCCURRING. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES HAIR IN PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER SUSPECTS THAT THERE WAS A BEARD HAIR IN THE STERILE PACKAGING. BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725314 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240320 00382903102051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown