BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27X1-1/4 RB

    MDR report key: 8902855 · Received August 16, 2019

    Report

    Report Number
    1911916-2019-00826
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    30382903051367
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE (3) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. TWO (2) SAMPLES WERE IN BLISTER PACKS AND WERE VISUALLY EXAMINED AND WERE FOUND TO BE CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE NEEDLES. ONE (1) NEEDLE WAS RETURNED ATTACHED TO SYRINGE. THE NEEDLE ASSEMBLY WAS REMOVED FROM THE SYRINGE AND WAS VISUALLY EXAMINED USING 10X MAGNIFICATION. IT WAS OBSERVED THAT THERE IS A SMALL HOLE APPROXIMATELY 0.1MM IN LENGTH IN THE NEEDLE HUB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. BASED ON THE DAMAGE OBSERVED IN THE NEEDLE HUB IT APPEARS THAT A SMALL SHARP OBJECT STRUCK THE NEEDLE HUB WHICH CREATED THE HOLE. AS THIS PRODUCT HAS SEEN ADDITIONAL HANDLING IT CANNOT BE DETERMINED WHERE THE DAMAGE OCCURRED; THEREFORE A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE CLOG/LEAKING OCCURRED DURING USE WITH A NEEDLE 27X1-1/4 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "YESTERDAY I WENT TO GIVE AN IM INJECTION WITH A 27G 1 ¼ IN NEEDLE FROM BD PRECISION GLIDE. AFTER THE NEEDLE WAS INSERTED INTO THE PT AND AS I WAS PUSHING THE MEDICATION IN I FOUND THAT THERE WAS A SMALL PINHOLE LEAK AT THE BASE OF THE NEEDLE. I WAS ABLE TO PLUG THE HOLE AND FINISH GIVING THE MEDICATION. AFTER WITCH I WHEN TO CHECKED THE OTHER NEEDLES. AFTER TESTING ABOUT 8 NEEDLES FROM OUR NEWEST LOT NUMBER (9030555) I FOUND TWO OTHER FAULTY NEEDLES. THEY WERE NOT FAULTY IN THE SAME WAY. THESE TWO DID NOT LEAK THEY WERE CLOGGED AND YOU COULD NOT PUSH FLUID THREW THEM. I PULLED ALL OF THE LATEST LOT NUMBER FROM THE SHELF." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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 THAT A NEEDLE CLOG/LEAKING OCCURRED DURING USE WITH A NEEDLE 27X1-1/4 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "YESTERDAY I WENT TO GIVE AN IM INJECTION WITH A 27G 1 ¼ IN NEEDLE FROM BD PRECISIONGLIDE. AFTER THE NEEDLE WAS INSERTED INTO THE PT AND AS I WAS PUSHING THE MEDICATION IN I FOUND THAT THERE WAS A SMALL PINHOLE LEAK AT THE BASE OF THE NEEDLE. I WAS ABLE TO PLUG THE HOLE AND FINISH GIVING THE MEDICATION. AFTER WITCH I WHEN TO CHECKED THE OTHER NEEDLES. AFTER TESTING ABOUT 8 NEEDLES FROM OUR NEWEST LOT NUMBER (9030555) I FOUND TWO OTHER FAULTY NEEDLES. THEY WERE NOT FAULTY IN THE SAME WAY. THESE TWO DID NOT LEAK THEY WERE CLOGGED AND YOU COULD NOT PUSH FLUID THREW THEM. I PULLED ALL OF THE LATEST LOT NUMBER FROM THE SHELF." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696479 NEEDLE 27X1-1/4 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 9030555 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other