BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19409749 · Received May 28, 2024

    Report

    Report Number
    3002682307-2024-00127
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    January 8, 2024
    Report Date
    May 28, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS A RESULT OF AN INVESTIGATION FINDING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 231101. 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) NEEDLE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE WAS MICROSCOPICALLY EXAMINED AND THE NEEDLE WAS FOUND TO BE CLOGGED WITH A SMALL PIECE OF VIAL MATERIAL. IT WAS CONCLUDED THAT A CLOGGED NEEDLE RESULTED FROM A CORING ISSUE. MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR CANNULA BEVEL. THIS CHANGE IN BEVEL MEANS THAT THE ANGLE OF PENETRATION DIFFERS. MATERIAL 303262 SHOULD PENETRATE THE VIAL BETWEEN 45-60 DEGREES TO MINIMIZE THE RISK OF CORING. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. 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; UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PROBLEM OBSERVED: DIFFICULTY IN ASPIRATING SALINE, THE CANULA SEEMS TO BE CLOGGED. IMMEDIATE ACTION: CHANGE DEVICE. PATIENT IMPACT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332073 BD CONVENTIONAL NEEDLES NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 231101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown