BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 1-1/2IN SB TW

    MDR report key: 8545017 · Received April 24, 2019

    Report

    Report Number
    3002682307-2019-00266
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH 10 REFERENCE SAMPLES OF CATALOG 304622 LOT 180933 TO INVESTIGATE FOR THIS RECORD. RETURNED NEEDLES WERE EXAMINED UNDER A MICROSCOPE WITHOUT OBSERVING NO DAMAGED CANNULA POINT AND WELL-DEBURRED. SAMPLES WERE TESTED USING A LAB VIAL WITH NO DIFFICULTIES AND NO PARTICLES FROM VIALS STOPPER FRAGMENTATION FOUND IN 9 NEEDLES. WHILE USING A WRONG ANGLE OF PENETRATION, RUBBER PARTICLES WERE NOTICED IN ONE NEEDLE. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. NO ABNORMALITIES OR ISSUES DURING THE NEEDLE MANUFACTURING WAS DETERMINED TO BE RELATED TO THE CORING EFFECT. IN ADDITION, THIS CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. AS VISUAL EXAMINATION, MEASUREMENTS AND PENETRATION TESTS ARE PERFORMED DURING THE CANNULA INSPECTION, UNFORTUNATELY A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. BASED ON ABOVE RESULTS AND SINCE DHR SHOW NO EVIDENCE, ABNORMALITIES AND NO ISSUES DURING NEEDLES MANUFACTURING RELATED TO CORING EFFECT AND TAKING INTO ACCOUNT THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. IN ADDITION, AS A PART OF FRAGA CANNULA INCOMING INSPECTION, VISUAL EXAMINATION (INCLUDING CANNULA POINT CONDITIONS, FLASHES, CLEANLINESS, CLOGGED AND CRASHED CANNULA), MEASUREMENTS AND PENETRATION TEST ARE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 18GA 1-1/2IN SB TW CORING ISSUE AFTER SAMPLING IN A VIAL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CORING ISSUE AFTER SAMPLING IN A VIAL. INJECTION WAS IMPOSSIBLE BECAUSE OF SMALL PIECES OF CORING VISIBLE IN THE SYRINGE. SAME ISSUE FOUND ON 6 OTHER UNITS FROM THE SAME BATCH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 18GA 1-1/2IN SB TW CORING ISSUE AFTER SAMPLING IN A VIAL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CORING ISSUE AFTER SAMPLING IN A VIAL. INJECTION WAS IMPOSSIBLE BECAUSE OF SMALL PIECES OF CORING VISIBLE IN THE SYRINGE. SAME ISSUE FOUND ON 6 OTHER UNITS FROM THE SAME BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340536 NEEDLE 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 180933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other