BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML LL BRAZIL

    MDR report key: 6751272 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00021
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 13, 2017
    Report Date
    October 2, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY, LOT NUMBER HISTORY REVIEW / QN REVIEW , COMPLAINT TRENDING REVIEW OF THE LOT FOR THIS ISSUE REVEALS THIS IS THE FIRST COMPLAINT. BASED ON QN REVIEW, THERE WERE NO NON-CONFORMANCE RELATING TO THIS DEFECT. NO SAMPLES OR PHOTOS WERE SENT BY THE CUSTOMER FOR ANALYSIS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURES 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. INVESTIGATION CONCLUSION: LOT NUMBER HISTORY REVIEW / QN REVIEW, COMPLAINT TRENDING REVIEW OF THE LOT FOR THIS ISSUE REVEALS THIS IS THE FIRST COMPLAINT. BASED ON QN REVIEW, THERE WERE NO NON-CONFORMANCE RELATING TO THIS DEFECT. 5290645-11/3/15- AT BLISTERPAK THERE WERE 20 INSPECTIONS ON 160 PARTS AND AT PRINT/ASSY THERE WERE 20 INSPECTIONS ON 1000 PARTS WITH ZERO DEFECTS FOUND. ROOT CAUSE DESCRIPTION: ROOT CAUSE POSSIBLE BROKEN PLUNGER ROD OCCURRED WHEN THE PLUNGER ROD AND STOPPER SUBASSEMBLY ARE PRESSED INTO THE SYRINGE BARREL AND A MISALIGNMENT BETWEEN THE BARREL AND SUBASSEMBLY OCCURRED. OR POSSIBLY WHEN PLUNGER ROD IS TRAVELING DOWN CHUTE FROM MEZZANINE TO PRODUCT LINE AND CHUTE WAS EMPTY THE RODS ARE DUMPED WITH TOO MUCH FORCE CAUSING CRACKING AND BREAKAGE. RATIONALE: NO CAPA IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLUNGER ON BD SYRINGE 60ML LL (B)(6) WAS DEFECTIVE PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532768 BD SYRINGE 60ML LL BRAZIL CONVENTIONAL SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5290645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other