BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LS S/C 56

    MDR report key: 8600157 · Received May 10, 2019

    Report

    Report Number
    1911916-2019-00463
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028338
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8082819, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-03-23. MEDICAL DEVICE LOT #: 8082821, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-03-23. INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS VISUALLY ANALYZED AND IT WAS CONFIRMED THAT A BROWN FOREIGN MATTER (FM) IS EMBEDDED IN THE SYRINGE BARREL AND FLANGE. 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. 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: BD ACKNOWLEDGES THAT THERE IS BROWN FOREIGN MATTER (FM) EMBEDDED IN THE SYRINGE BARREL AND FLANGE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER FOR LOT #8082819 ITEM #302833. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: EMBEDDED FM CAN OCCUR AT THE STARTUP OF THE INJECTION MOLDING PROCESS. SOLIDIFIED RESIN WITHIN THE MOLD AND MOLDING PRESS MAY BECOME DISCOLORED OR DEGRADED WHEN REHEATED. THIS IS A COSMETIC DEFECT ONLY AND DOES NOT AFFECT THE INTEGRITY OF THE SYRINGE. RATIONALE: ON 08-MAY-2018 A QUALITY ALERT WAS GIVEN TO THE ASSOCIATES INVOLVED IN THE PRODUCTION OF THIS PRODUCT. NOW WHEN STARTING THE MOLDING PROCESS, THE PRESS IS PUT INTO "STARTUP" WHERE THE PRESS RUNS UNTIL ANY POTENTIAL FM IS FLUSHED THROUGH THE SYSTEM. THE PRESS REMAINS IN STARTUP UNTIL NO FM IS DETECTED IN INSPECTIONS. THE BATCHES ASSOCIATED WITH THIS COMPLAINT WERE PRODUCED IN MARCH OF 2018 BEFORE THIS QUALITY ALERT. AS A CONSEQUENCE, NO ADDITIONAL CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON 50 SYRINGES 30ML LS S/C 56 FROM LOT # 8082819, AND 50 SYRINGES FROM LOT # 8082821, BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THIS HOSPITAL EQUIPMENT SECTION TEACHER COMPLAINS, RECEIVES EACH SECTION TEACHER TO REPORT THE SYRINGE WITH THE BROWN FOREIGN MATTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391400 SYRINGE 30ML LS S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10. 30382903028338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other