BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL

    MDR report key: 10029246 · Received May 6, 2020

    Report

    Report Number
    1911916-2020-00437
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 18, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. HOWEVER, IT MAY HAVE HAPPENED A JAM AT THE PLUNGER ROD- STOPPER ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE BARREL AND NOT DETECTED IN THE NEXT PROCESSES. 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. 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: THIS IS THE 1ST COMPLAINT FOR LOT # 9242395 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: PLUNGER ROD-STOPPER ASSEMBLY PROCESS. IT MAY HAVE HAPPENED A JAM AT THE PLUNGER ROD- STOPPER ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE BARREL AND NOT DETECTED IN THE NEXT PROCESSES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML SALINE FILL EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 11:00 ON (B)(6) 2020, WHEN THE NURSE PERFORMED SUBCLAVIAN CENTRAL VENOUS CATHETER SEALING FOR THE PATIENT AFTER FLUID INFUSION, IT WAS FOUND THAT THE BARREL OF THE 10ML PREFILLED SYRINGE BROKEN, AND A NEW 10ML PREFILLED SYRINGE WAS IMMEDIATELY REPLACED, THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494982 SYRINGE 10ML SALINE FILL SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9242395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other