BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 10317899 · Received July 23, 2020

    Report

    Report Number
    1911916-2020-00679
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: FOUR SAMPLES WERE RECEIVED FOR INVESTIGATION. THREE CAME IN SEALED PACKAGING BLISTER AND ONE WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. ALL FOUR SAMPLES HAVE NO SCALE PRINTING. THE POTENTIAL ROOT CAUSE IS DUE TO SYRINGE ASSEMBLY PRINTING PROCESS. AFTER THE BARREL MOLDING PROCESS, THE BARREL GOES TO THE BARREL PRINTING PROCESS. IT MAY HAVE HAPPENED THAT THE MACHINE RAN LOW IN INK. THE BARREL PRINTING WAS NOT DONE AND NOT DETECTED IN THE NEXT PROCESSES. BASED ON THE SAMPLE ANALYSIS AND INVESTIGATION CARRIED OUT, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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 # 0062316 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. BASED ON THE SAMPLE ANALYSIS AND INVESTIGATION CARRIED OUT THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THE LOT WAS PRODUCED FOR (B)(4) UNITS, THIS IS THE 1ST COMPLAINT; THEREFORE THE CPM IS 7.4. WE WILL CONTINUE MONITORING AND TRENDING THIS PRODUCT AND THIS SYMPTOM. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE IS DUE TO SYRINGE ASSEMBLY PRINTING PROCESS. AFTER THE BARREL MOLDING PROCESS, THE BARREL GOES TO THE BARREL PRINTING PROCESS. IT MAY HAVE HAPPENED THAT THE MACHINE RAN LOW IN INK. THE BARREL PRINTING WAS NOT DONE AND NOT DETECTED IN THE NEXT PROCESSES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED SCALE MARKING ISSUES AND MISSING SCALE MARKINGS. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653 BATCH NO.: 0062316. IT WAS REPORTED THAT SOME OF THE SYRINGES ARE MISSING THE MARKINGS AND SOME OF THE MARKINGS ARE CROOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782247 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062316 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other