BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 9034605 · Received September 13, 2019

    Report

    Report Number
    2243072-2019-02010
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 24, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED A SAMPLE FOR CATALOG 309110 LOT 1904218 TO INVESTIGATE FOR THIS RECORD. A PIECE OF WHITE PAPER FIBER WAS DETECTED IN THIS RETURNED SAMPLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE WHITE PARTICLE INSIDE THE SYRINGE BARREL HAS BEEN IDENTIFIED AS PAPER FIBERS PIECE, THE MOST PROBABLY ORIGIN OF THIS PAPER FIBERS PIECE IS THE WHITE PAPER USED DURING SOME CLEANING ACTIVITIES IN THE ASSEMBLY MACHINE. IN THIS CASE, DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, FINALLY THIS FOREIGN MATTER ENDED IN THE ASSEMBLY MACHINE WHICH PRODUCED THE MENTIONED NON-CONFORMANCE. 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. EVEN THOUGH ANY HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. BD CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE. CONCLUSION: THE PAPER FIBERS PIECE WAS LOST DUE TO THE OPERATOR MANIPULATION OF IT DURING THE ASSEMBLY MACHINE ROUTINE CLEANING ACTIVITIES AND FINALLY ENDED INSIDE THE SYRINGE. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND FLOATING IN THE BD DISCARDIT¿ II SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "A PARTICLE FLOATED IN A 10-DISCARDIT SYRINGE."

    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 FOREIGN MATTER WAS FOUND FLOATING IN THE BD DISCARDIT¿ II SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A PARTICLE FLOATED IN A 10-DISCARDIT SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826179 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other