BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL

    MDR report key: 9767828 · Received February 28, 2020

    Report

    Report Number
    1911916-2020-00195
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    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. FROM THE COMPLAINT VERBATIM IT APPEARS THE BARREL WAS DAMAGED, POSSIBLY CRACKED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9140777 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: DIVERTER AT THE PACKAGING PROCESS. IT COULD HAVE HAPPENED THAT A JAM OCCURRED AT THE DIVERTER INDUCING DAMAGE TO THE BARREL. NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL EXPERIENCED SYRINGE BARREL OR FLANGE DAMAGED/CRACKED/DEFORMED. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS TREATED WITH INTRAVENOUS INDWELLING NEEDLE, AND THE FLUSH'S BARREL WAS RUPTURED WHILE FILLING THE INDWELLING CATHETER FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235598 SYRINGE 5ML SALINE FILL SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other