BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 9411921 · Received December 4, 2019

    Report

    Report Number
    3002682307-2019-00646
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PHOTO AND SAMPLE FOR CATALOG 301947,LOT 1901230 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO AND SAMPLE IDENTIFIED A HAIR BETWEEN THE HUB OF THE NEEDLE AND THE NEEDLE SHIELD WAS DETECTED. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE HAIR WAS LOST DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, OR NEGLECT, OR AS PART OF SOME RAW MATERIALS. FINALLY THIS FOREIGN MATTER ENDED IN THE ASSEMBLY MACHINE WHICH PRODUCED THE MENTIONED NON-CONFORMANCE. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARD IT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HAIR-LIKE FOREIGN MATTER WAS FOUND AT THE BD¿ SYRINGE WITH NEEDLE HUB, EMBEDDED BETWEEN THE HOLDER AND CAP, BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE WARD TEACHER OPENED THE PACKAGE, HE FOUND A FOREIGN MATTER SUSPECTED OF HAIR AT THE NEEDLE HUB. THE FOREIGN MATTER IS EMBEDDED BETWEEN THE NEEDLE HOLDER AND THE NEEDLE CAP. THEREFORE, THE STERILITY OF THE SYRINGE IS SUSPECTED AND IT IS NOT USED FOR CLINICAL OPERATIONS."

    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 HAIR-LIKE FOREIGN MATTER WAS FOUND AT THE BD¿ SYRINGE WITH NEEDLE HUB, EMBEDDED BETWEEN THE HOLDER AND CAP, BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE WARD TEACHER OPENED THE PACKAGE, HE FOUND A FOREIGN MATTER SUSPECTED OF HAIR AT THE NEEDLE HUB. THE FOREIGN MATTER IS EMBEDDED BETWEEN THE NEEDLE HOLDER AND THE NEEDLE CAP. THEREFORE, THE STERILITY OF THE SYRINGE IS SUSPECTED AND IT IS NOT USED FOR CLINICAL OPERATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208979 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other