BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18651443 · Received February 6, 2024

    Report

    Report Number
    3002682307-2024-00019
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 17, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBERS 231010 AND 230912. 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, TWO (2) NEEDLE SAMPLES FROM LOT 230912 AND ONE (1) NEEDLE SAMPLE FROM LOT 231010 WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE MICROSCOPICALLY EXAMINED AND A PARTICLE THAT WAS CONICAL IN SHAPE, SOFT AND TRANSPARENT WAS OBSERVED WITHIN THE NEEDLE. THE REPORT OF ¿TWO HOLES IN NEEDLE¿ IS LIKELY BECAUSE THE NEEDLE WAS PARTIALLY CLOGGED, CAUSING THE LIQUID TO DISPERSE IN A SPLIT FLOW. 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 PARTICLES 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.

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    RESPONSE RECEIVED - 25/JAN/2024 - WHEN WAS THE DEFECT (HOLES ON THE NEEDLE) IDENTIFIED? (BEFORE USE / DURING CLINICAL USE) DURING DRUG PREPARATION - IS THERE AN IMPACT ON THE PATIENT? NO IMPACT ON THE PATIENT, JUST A FEW MINUTES OF PREPARATION DELAY. THE CONCERN IS IF IT HAPPENS DURING AN EMERGENCY. - ARE LEAKS OBSERVED? ONLY DILUENT LEAKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE HAS TWO HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THEY INDICATE THE PRESENCE OF TWO HOLES IN THE NEEDLE. RESPONSE RECEIVED - 25/JAN/2024 - (B)(4) WHEN WAS THE DEFECT (HOLES ON THE NEEDLE) IDENTIFIED? (BEFORE USE / DURING CLINICAL USE) DURING DRUG PREPARATION IS THERE AN IMPACT ON THE PATIENT? NO IMPACT ON THE PATIENT, JUST A FEW MINUTES OF PREPARATION DELAY. THE CONCERN IS IF IT HAPPENS DURING AN EMERGENCY. ARE LEAKS OBSERVED? ONLY DILUENT LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087399 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown