BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS 21X1-1/2 AN EMERALD

    MDR report key: 10185219 · Received June 23, 2020

    Report

    Report Number
    3002682307-2020-00195
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-29. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2003123 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, BLACK FOREIGN PARTICLES WERE OBSERVED WITHIN ONE OF THE BLISTER PACKAGES AND INCOMPLETE PERFORATION WAS OBSERVED ON FIFTY-EIGHT OF THE RETURNED PACKAGES. THE BLACK FOREIGN MATTER WAS IDENTIFIED AS DUST PARTICLES FROM THE PRIMARY PACKAGING PROCESS. THE BLACK DUST PARTICLES RESULT FROM THE DIES USED IN THE PACKAGING PROCESS. THERE ARE VARIOUS PREVENTIVE MEASURES IN PLACE TO REMOVE THIS RESIDUE FROM THE PRODUCTION LINE, HOWEVER, AN ERROR MUST HAVE OCCURRED RESULTING IN THIS PARTICULAR INCIDENT. THE UNCUT PERFORATION MARKS ALSO RESULTED FROM AN ERROR IN THE PACKAGING PROCESS, SPECIFICALLY AN ERROR RELATED TO THE CUTTING SYSTEM'S BLADE ALIGNMENT. WE BELIEVE THAT BOTH OF THESE ISSUES WERE ISOLATED INCIDENTS WITH UNLIKELY CHANCES OF RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THESE POTENTIAL DEFECTS AND ANY SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LS 21X1-1/2 AN EMERALD PACKAGE HAD POOR PERFORATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: -1 PIECE WITH FOREIGN PARTICLES ON THE SYRINGE AND INSIDE THE BLISTER. THIS DEFECT IS CRITICAL, AS IT HAS BEEN DETECTED ON A STERILE MEDICAL DEVICE THAT HAS BEEN MARKETED. 58 PIECES WITH PACKAGING DAMAGED/BROKEN WHILE SEPARATING THE SYRINGES DUE TO IMPERFECTIONS OF THE DOTTED SEPARATION LINE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LS 21X1-1/2 AN EMERALD PACKAGE HAD POOR PERFORATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 PIECE WITH FOREIGN PARTICLES ON THE SYRINGE AND INSIDE THE BLISTER. THIS DEFECT IS CRITICAL, AS IT HAS BEEN DETECTED ON A STERILE MEDICAL DEVICE THAT HAS BEEN MARKETED. 58 PIECES WITH PACKAGING DAMAGED/BROKEN WHILE SEPARATING THE SYRINGES DUE TO IMPERFECTIONS OF THE DOTTED SEPARATION LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646675 SYRINGE 10ML LS 21X1-1/2 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 2003123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other