BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 10080779 · Received May 21, 2020

    Report

    Report Number
    9610847-2020-00156
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    March 18, 2020
    Report Date
    May 15, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 9211311. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-08-28. MEDICAL DEVICE LOT#: 9242239. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-09-09. MEDICAL DEVICE LOT #: 9175601 MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-07-01. INVESTIGATION SUMMARY: THIRTY-ONE SAMPLES WERE RECEIVED FOR EVALUATION. THEY ALL HAVE AN AREA CIRCLED WITH PERMANENT MARKER WHERE THE EMBEDDED FOREIGN MATTER WAS IDENTIFIED. THE AREA WHERE EMBEDDED FOREIGN MATTER WAS IDENTIFIED HAS SCRATCHES DONE TO CONFIRM THEY ARE EMBEDDED. ADDITIONALLY, TWENTY-SEVEN PHOTO SAMPLES WERE PROVIDED FOR EVALUATION. THE EMBEDDED FOREIGN MATTER CAN ALSO BE SEEN IN THE PHOTOS PROVIDED. THE EMBEDDED FOREIGN MATTER IS BURNT PLASTIC. BASED ON THE SAMPLES AND PHOTOS PROVIDED THEY ARE OF A SIZE THAT IS ACCEPTABLE. PARTICLES LEVEL 2 OR SMALLER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: EMBEDDED BURNT PLASTIC CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAS FOREIGN MATTER EMBEDDED. THIS OCCURRED ON 25 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680 BATCH NO: 9211311, 9242239, 9175601. IT WAS REPORTED THAT SYRINGES HAVE EMBEDDED MATERIAL. PER CUSTOMER RESPONSE: IS THE EMBEDDED MATERIAL ON THE INSIDE OR THE OUTSIDE OF THE SYRINGE? WE HAVE USED A TOOL TO HELP US IDENTIFY THIS AND THE EMBEDDED MATERIAL IS DEEP WITHIN THE SYRINGE WALLS ON BOTH SIDES, THE EXTERNAL AND INTERNAL PART OF THE SYRINGE HAS BEEN *SCRAPED* AND THE EMBEDDED MATERIAL HAS STAYED PUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541730 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309680 SEE H.10 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other