BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 8856252 · Received August 2, 2019

    Report

    Report Number
    3002682307-2019-00432
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 19, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH AFFECTED SAMPLES FOR CATALOG 30773319 LOT 1811391 TO INVESTIGATE FOR THIS RECORD. A HAIR BETWEEN THE HUB OF THE NEEDLE AND THE NEEDLE SHIELD WAS DETECTED IN THIS RETURNED SAMPLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PROBABLE ROOT CAUSE WAS A HAIR WAS LOST DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, OR A NEGLECT USE OF SOME RAW MATERIALS. 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 EMERALD 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. 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. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE HAD FOREIGN MATTER IN THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FOREIGN MATTER IN THE NEEDLE HUB DURING PRIMING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE HAD FOREIGN MATTER IN THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT FOREIGN MATTER IN THE NEEDLE HUB DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648106 BD EMERALD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other