BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 9239367 · Received October 25, 2019

    Report

    Report Number
    1213809-2019-01069
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 9, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE (3) SAMPLES WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. THE THREE (3) SAMPLES WERE VISUALLY EXAMINED USING 10X MAGNIFICATION. ONE (1) OF THE RETURNED SAMPLES HAD BLACK FOREIGN MATTER EMBEDDED IN THE NEEDLE HUB. NO FOREIGN MATTER WAS OBSERVED ON THE OTHER TWO (2) RETURNED SAMPLES. POSSIBLE ROOT CAUSE, EMBEDDED FOREIGN MATTER CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. BD ACKNOWLEDGES THAT ONE (1) OF THE RETURNED SAMPLES HAD BLACK FOREIGN MATTER EMBEDDED IN THE NEEDLE HUB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE COLUMBUS BATCHES (9059524, 9059520, 9059526, 9059551, 9059517) USED AS COMPONENTS IN THE CANAAN BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 25X1 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305916 BATCH NO.: 9150893 VERBATIM: THE INCIDENT INVOLVES 25G X1 BD SAFETY GLIDE NEEDLE THERE IS SOMETHING BLACK EMBEDDED IN THE HUB OF THE NEEDLE. SAID THEY HAVEN'T SEEN ANYMORE, BUT THEY ARE CHECKING AS THESE ARE THE NEEDLES WE ARE USING FOR THE FLU SHOTS.

    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 THE NEEDLE SFTYGLD 25X1 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305916 , BATCH NO.: 9150893. VERBATIM: THE INCIDENT INVOLVES 25G X1 BD SAFETY GLIDE NEEDLE THERE IS SOMETHING BLACK EMBEDDED IN THE HUB OF THE NEEDLE. SAID THEY HAVEN'T SEEN ANYMORE, BUT THEY ARE CHECKING AS THESE ARE THE NEEDLES WE ARE USING FOR THE FLU SHOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037325 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9150893 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other