BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23GA 1-1/4IN

    MDR report key: 12450153 · Received September 9, 2021

    Report

    Report Number
    3002682307-2021-00469
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 9, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/26/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210232. 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, FIVE PACKAGED NEEDLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, GRAYISH FOREIGN MATTER COULD BE OBSERVED WITHIN THE BLISTER PACKAGE. IT HAS BEEN DETERMINED THAT THE GRAYISH FOREIGN MATTER MOST LIKELY ORIGINATED FROM RESIDUE OF ANY AUXILIAR COMPONENT OF THE PACKAGING MACHINE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DARK, MOLDY PARTICLES WERE FOUND ON THE NEEDLE 23GA 1-1/4IN AND IN ITS PACKAGING WHILE RECONSTITUTING THE PFIZER/BIONTECH VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "IN THE COURSE OF RECONSTITUTION OF THE PFIZER/BIONTECH VACCINE, IT WAS DISCOVERED THAT TWO OF THE NEEDLES INTENDED FOR USE WERE HEAVILY CONTAMINATED WITH PARTICLES IN THE SUPPOSEDLY STERILE PACKAGING. BOTH PACKAGES HAD SEVERAL DARK, MOLD-LIKE PARTICLES VISIBLE. SINCE THIS WAS THE LAST BLISTER OF A 100 PCS. PACKAGE, THE LARGEST PART WAS ALREADY USED BEFORE THE LAST 3 CANNULAS WERE DISCARDED."

    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 DARK, MOLDY PARTICLES WERE FOUND ON THE NEEDLE 23GA 1-1/4IN AND IN ITS PACKAGING WHILE RECONSTITUTING THE PFIZER/BIONTECH VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IN THE COURSE OF RECONSTITUTION OF THE PFIZER/BIONTECH VACCINE, IT WAS DISCOVERED THAT TWO OF THE NEEDLES INTENDED FOR USE WERE HEAVILY CONTAMINATED WITH PARTICLES IN THE SUPPOSEDLY STERILE PACKAGING. BOTH PACKAGES HAD SEVERAL DARK, MOLD-LIKE PARTICLES VISIBLE. SINCE THIS WAS THE LAST BLISTER OF A 100 PCS. PACKAGE, THE LARGEST PART WAS ALREADY USED BEFORE THE LAST 3 CANNULAS WERE DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345734 NEEDLE 23GA 1-1/4IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown