BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 RB TW

    MDR report key: 19255086 · Received May 6, 2024

    Report

    Report Number
    3002682307-2024-00093
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 231015. 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) SAMPLE NEEDLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. ONE (1) NEEDLE SHOWED NO CLOGGING, WITH LIGHT AND LIQUID ABLE TO PASS THROUGH THE CANNULA. THE SECOND NEEDLE DID APPEAR CLOGGED. THROUGH MICROSCOPIC EXAMINATION, THE CLOGGED MATERIAL WAS WHITE AND SEEMED TO BE PART OF A VIAL SEPTUM. BASED ON THE PROVIDED FEEDBACK AND THE SAMPLE EVALUATION, WE CONFIRM THAT AN ISSUE OF CORING TOOK PLACE WHICH CAUSED NEEDLE CLOGGING. WE WOULD LIKE TO INFORM YOU THAT NEW 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. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE MANUFACTURING PROCESS, IT IS UNLIKELY THAT THE CORING WAS CAUSED BY 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. PLEASE FIND ATTACHED THE JOB AID ¿(B)(4) HOW TO REDUCE CORING WITH A SHARP NEEDLE¿ WHICH EXPLAINS HOW THE HANDLING SHOULD BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB TW WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "HI, NURSES HAD PROBLEMS WITH REFERENCE 303262 (NEEDLE 18X1-1/2 RB TW) THEY ARE BLOCKED (NO POSSIBILITY OF ASPIRATING)." ADDITIONAL INFORMATION PROVIDED ON 04/16/24 TRANSLATED FROM FRENCH TO ENGLISH: "NO EFFECT ON PATIENTS OR STAFF, ONLY NEEDLES WHICH ARE SOMETIMES CLOGGED OR OBSTRUCTED WHICH PREVENTS ASPIRATING OR INJECTING THROUGH REF 303262 LOT 231015. WE ARE IN THE PROCESS OF RECOVERING ALL THE NEEDLES FROM THE BATCH THAT IS CAUSING US PROBLEMS, SO IT IS IN PROGRESS, THERE WILL BE THE EQUIVALENT OF AROUND FIFTEEN BOXES OF 100 NEEDLES BUT I DO NOT HAVE THE EXACT NUMBER AT THIS TIME. DAY. WE HAVE A NEEDLE THAT IS BLOCKED TO RETURN TO YOU FOR EXAMPLE BUT THE PROBLEM HAS ARISEN MANY TIMES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599510 BD NEEDLE 18X1-1/2 RB TW NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 231015 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown