BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14131492 · Received April 16, 2022

    Report

    Report Number
    3002682307-2022-00112
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2108228. MEDICAL DEVICE EXPIRATION DATE: 2026-07-31. DEVICE MANUFACTURE DATE: 2021-08-19. MEDICAL DEVICE LOT #: 2102190. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-02-10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES D9: RETURNED TO MANUFACTURER ON: 23-MAY-2022. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2102190 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 ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, WHITE PARTICLES WERE FOUND INSIDE THE SYRINGE BARREL. WE HAVE CONCLUDED THAT THE PARTICLES ARE COMPOSED OF THE SLIP AGENT USED IN THE MANUFACTURE OF THIS SYRINGE PRODUCT. THIS SLIP AGENT IS USED TO FACILITATE THE MOVEMENT OF THE PLUNGER ALONG THE BARREL. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPIC LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. THIS IS A NORMAL PROCESS AND THE SYRINGE WOULD NOT WORK WITHOUT THE PRESENCE OF THIS LUBRICANT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE HAD FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER INFORMED US THAT PLASTIC PARTICLES WOULD BREAK OFF THE STAMP AND WOULD CAUSE TO INFUSE THEM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE HAD FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER INFORMED US THAT PLASTIC PARTICLES WOULD BREAK OFF THE STAMP AND WOULD CAUSE TO INFUSE THEM.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907078 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown