BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE

    MDR report key: 8916273 · Received August 21, 2019

    Report

    Report Number
    3002682307-2019-00459
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 29, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED SAMPLES AND PHOTOS FOR CATALOG 307737 LOT 1905312 TO INVESTIGATE FOR THIS RECORD. THE BROKEN PACKAGE ISSUE WAS IDENTIFIED AS DEFECT CUTTING OF THE BLISTER. THE FOREIGN MATTER WAS ALSO IDENTIFIED AS STAINS IN THE PACKAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE FOREIGN MATTER IS COMPOSED BY BLACK PARTICLES COMING FROM THE DYES OF THE PRIMARY PACKAGING MACHINE. WHEN BD PRODUCES THE ATTACHED NEEDLE PRODUCT (AN), BD MUST CHANGE THE DYES TO ALLOW THE PACKAGING OF THIS AN PRODUCT. AFTER THIS CHANGE, BD RUNS THE MACHINE SCRAPING PRODUCT FOR A TIME, TRYING TO REMOVE EVERY FOREIGN PARTICLE WHICH COULD REMAIN IN THE BLISTER AFTER THE STARTUP OF THE MACHINE. IN THIS CASE, THIS PROTOCOL WAS NOT PERFORMED CORRECTLY, AND SOME BLACK PARTICLES WERE PRESENT IN THE BLISTER, PRODUCING THE REPORTED ISSUE. THE REPORTED DEFECT OF DEFECTIVE CUTTING OF THE BLISTERS WAS PRODUCED IN THE PRIMARY PACKAGING MACHINE. THIS MACHINE HAS A CUTTING SYSTEM AND IN THIS STAGE THE DIFFERENT STRIPS ARE CUT. THE NON-CONFORMANCE WAS PRODUCED DUE TO A PUNCTUAL FAILURE OF THE CUTTING SYSTEM. THE BLADES OF THE CUTTING SYSTEM DID NOT WORK AS EXPECTED SO IT PRODUCED THE EXISTENCE OF DIFFERENT UNCUT BLISTERS, WHICH PRODUCED DIFFICULTIES TO OPEN THE BLISTER. 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. 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. WE CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE. CONCLUSION: FAILURE DURING THE SCRAPPING PROTOCOL FOR AN PRODUCT DYE CHANGE. DEFECTIVE CUTTING DUE TO A PUNCTUAL FAILURE IN THE BLADES OF THE CUTTING SYSTEM. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE HAS BEEN FOUND EXPERIENCING 84 OCCURRENCES OF PACKAGING ISSUES AND SEVEN INSTANCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: 1 TORN PACKAGE DURING THE KIT ASSEMBLY CAUSED BY THE NOT WELL DEFINED PRE-CUT 2 SPOT ON THE BLISTER AND ON THE DEVICE.

    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 HAS BEEN REPORTED THAT THE BD EMERALD¿ SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE HAS BEEN FOUND EXPERIENCING 84 OCCURRENCES OF PACKAGING ISSUES AND SEVEN INSTANCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: 1 TORN PACKAGE DURING THE KIT ASSEMBLY CAUSED BY THE NOT WELL DEFINED PRE-CUT, 2 SPOTS ON THE BLISTER AND ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712859 BD EMERALD SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1905312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other