BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20456020 · Received October 15, 2024

    Report

    Report Number
    3002682307-2024-00210
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 22, 2024
    Report Date
    December 19, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 303262 AND LOT NUMBERS 230408. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND A CORING ISSUE TOOK PLACE. HOWEVER, BASED ON THE INVESTIGATION RESULTS AND THE PREVENTIVE MEASURES IN PLACE, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. WE WOULD LIKE TO INFORM YOU THAT MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR BEVEL, COMPARED TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. THIS MEANS THAT THE NEEDLE NEEDS TO PUNCTURE THE VIAL DIFFERENTLY. MATERIAL 303262 SHOULD PUNCTURE THE VIAL AT AN ANGLE OF PENETRATION 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, FOREIGN MATTER OCCLUDES NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE TROCARS (PINK NEEDLE 18G X 40MM) ARE BLOCKED. INCIDENTS OCCUR-DURING USE . THE TROCARS (PINK NEEDLE 18G X 40MM) ARE BLOCKED. WHEN WE WANT TO ASPIRATE A LIQUID, THERE'S A LOT OF PRESSURE. WHEN WE WANT TO INJECT, THERE'S ALSO PRESSURE, AND THEN A SMALL PIECE OF IT COMES OUT OF THE TROCAR, AND IT WORKS AGAIN. WE'RE VERY CURIOUS ABOUT THE PIECE THAT COMES OFF THE TROCAR: AN UNIDENTIFIED PARTICLE THAT ESCAPES FROM THE TROCAR AND MIXES WITH OUR INJECTABLE PREPARATIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572241 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 230408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown