BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19215271 · Received April 30, 2024

    Report

    Report Number
    3002682307-2024-00089
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    November 30, 2023
    Report Date
    April 25, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS CREATED AS A RESULT OF THE INVESTIGATION FINDINGS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230901. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLE WAS MICROSCOPICALLY EXAMINED AND A TRANSPARENT PARTICLE WAS OBSERVED OBSTRUCTING THE NEEDLE. THE MATERIAL WAS IDENTIFIED AS A VIAL SEPTUM. BASED ON THE SAMPLE ANALYSIS, WE CAN CONFIRM THAT AN INSTANCE OF CORING OCCURRED WHICH RESULTED IN A CLOGGED NEEDLE. MATERIAL 303262 HAS A REGULAR BEVEL IN COMPARISON TO MATERIAL 304322 WHICH HAD A SHORT BEVEL. THIS MEANS THAT THE WAY THE NEEDLE PUNCTURES THE VIAL CHANGES. FOR MATERIAL 303262, THE ANGLE OF PENETRATION FOR THE VIAL SHOULD BE BETWEEN 45 TO 60 DEGREES. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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 WAS DIFFICULT TO ASPIRATE FROM VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFICULTY INJECTING OR SAMPLING. THIS SITUATION HAS BEEN ENCOUNTERED FOR SEVERAL MONTHS, BUT NOT ON EVERY NEEDLE. TO DATE, THERE HAS BEEN A SIGNIFICANT INCREASE IN THE NUMBER OF DEFECTIVE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137877 BD CONVENTIONAL NEEDLES NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown