BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 18388704 · Received December 22, 2023

    Report

    Report Number
    3002682307-2023-00362
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 29, 2023
    Report Date
    April 24, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230913. 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, THE AFFECTED PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE PHYSICAL SAMPLE WAS EXAMINED UNDER MICROSCOPE AND A CONICAL SHAPED, SOFT, TRANSPARENT PARTICLE WAS OBSERVED INSIDE OF THE NEEDLE. BD HAS INVESTIGATED THIS TYPE OF CLOGGING ISSUE IN THE PAST WITH DIFFERENT ANALYSES AND FOURIER-TRANSFORM INFRARED (FTIR) SPECTROSCOPY PERFORMED. PAST INVESTIGATIONS HAVE CONCLUDED THAT THE CLOGGED MATERIAL WAS POLYETHYLENE (PE). IT WAS OBSERVED THAT THESE TYPES OF PARTICLE ARE COMMONLY GENERATED WHEN NEEDLES ARE USED TO ACCESS THE SEPTUM OF RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS. FURTHER INVESTIGATION SUGGESTED THAT THE BD MICROLANCE¿ NEEDLE HAD BEEN USED TO ACCESS RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS DESIGNED TO HAVE A DOUBLE SEPTUM, THE FIRST IS A NORMAL RUBBER CLOSURE, THE SECOND IS A THICK POLYETHYLENE SEPTUM. ACCORDING TO THE ABOVE CONCLUSIONS, WE HAVE TO CONSIDER THAT BD MICROLANCE¿ NEEDLES ARE DESIGNED AND MANUFACTURED TO PENETRATE THE SKIN AND RUBBER CLOSURES OF VIALS. THEY ARE NOT DESIGNED TO PENETRATE THICK POLYETHYLENE MEMBRANES. DEDICATED DEVICES ARE AVAILABLE FROM THE SUPPLIER OF THE RIGID PLASTIC CONTAINERS. BD RECOMMENDS CONTACTING THE MANUFACTURER OF THE CONTAINER FOR A DETAILED LIST OF THESE ACCESSORIES. FOR NEEDLE MATERIAL 303262, THE CANNULA HAS A REGULAR BEVEL, WHICH MEANS THE ANGLE OF PENETRATION SHOULD BE FROM 45-60 DEGREES (WHICH DIFFERS FROM SHORT BEVEL CANNULAS). THIS ANGLE OF PENETRATION MINIMIZES THE RISK OF CORING. 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 NEEDLE HAS A PARTIAL BLOCKAGE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: MORE AND MORE DRUG SAMPLING TROCARS ARE DEFECTIVE, WITH EXTREMELY SLOW FLOW RATES SERVICE ACTION: TROCAR CHANGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232745 BD CONVENTIONAL NEEDLES NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230913 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown