BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 1-1/2IN SB TW

    MDR report key: 12450830 · Received September 9, 2021

    Report

    Report Number
    3002682307-2021-00471
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-07. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210632. 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, EIGHT PACKAGED NEEDLES AND A BOTTLE OF SODIUM BICARBONATE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE BOTTLE WAS EXAMINED AND NO PARTICLES COULD BE IDENTIFIED WITHIN IT. THE EIGHT NEEDLES WERE FUNCTIONALLY TESTED, USING DIFFERENT ANGLES OF PENETRATION ON A LAB VIAL WITH A PLASTIC STOPPER. NO DIFFICULTIES OCCURRED DURING THE NEEDLE PUNCTURING PROCESS. THROUGH MICROSCOPIC INSPECTION, NO PARTICLES FROM THE VIAL STOPPERS WERE FOUND IN ANY OF THE SAMPLES AND THE NEEDLE BEVELS WERE ALL FOUND TO BE WELL FORMED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. PER THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE OF CORING TOOK PLACE. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. AS PART OF THE CANNULA INCOMING INSPECTION, VISUAL EXAMINATION, MEASUREMENTS, AND PENETRATION TESTS ARE PERFORMED. STOPPER CONDITIONS AND THE HANDLING OF THE PRODUCT CANNOT BE EXCLUDED AS POTENTIAL FACTORS IN THE ISSUE OF CORING. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE NEEDLE 18GA 1-1/2IN SB TW, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE DEVICE (CORING). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A NURSE IN SURGERY REPORTED TO ME THAT WHEN USING BD NEEDLES TO EXTRACT THE PRODUCT FROM A (NON BD) VIAL, AN IMPORTANT PARTICLE WAS DETACHED (CORE OF THE SAME ASPECT AS THE VIAL MEMBRANE) THIS COULD BE SUCKED UP BY THE WITHDRAWAL SYRINGE, THE PARTICLE COULD BE VISIBLE AGAIN IN THE INFUSION BAG ONCE THE SOLUTION WAS REINJECTED, THIS IS NOT AN ASSUMPTION BUT AN OBSERVED AND REPRODUCED FACT. THE CASE IS NOT ISOLATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE NEEDLE 18GA 1-1/2IN SB TW, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE DEVICE (CORING). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A NURSE IN SURGERY REPORTED TO ME THAT WHEN USING BD NEEDLES TO EXTRACT THE PRODUCT FROM A (NON BD) VIAL, AN IMPORTANT PARTICLE WAS DETACHED (CORE OF THE SAME ASPECT AS THE VIAL MEMBRANE) THIS COULD BE SUCKED UP BY THE WITHDRAWAL SYRINGE, THE PARTICLE COULD BE VISIBLE AGAIN IN THE INFUSION BAG ONCE THE SOLUTION WAS REINJECTED, THIS IS NOT AN ASSUMPTION BUT AN OBSERVED AND REPRODUCED FACT. THE CASE IS NOT ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347239 NEEDLE 18GA 1-1/2IN SB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210632

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown