BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7657119 · Received July 2, 2018

    Report

    Report Number
    1213809-2018-00392
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 11, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: TWENTY TWO SEALED 3ML PACKAGED SYRINGES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8061823 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MISSING PRINT. THE MAJORITY OF THE SYRINGES WERE ENTIRELY BLANK. MISSING PRINT OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CAN BE VERIFIED. PRINTING RECORDS WERE REVIEWED AS PART OF THIS DEVICE HISTORY RECORD REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. PRINT DEFECTS, INCLUDING JAMMED PART AT PRINTER WERE DOCUMENTED DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE AND PRODUCT WAS REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 8061823 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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: TWENTY TWO SEALED 3ML PACKAGED SYRINGES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8061823 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MISSING PRINT. THE MAJORITY OF THE SYRINGES WERE ENTIRELY BLANK. MISSING PRINT OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CAN BE VERIFIED. DHR REVIEW FOR BATCH 8061823 (P/N 309657): MANUFACTURING DATES: 03/12/2018 - 03/14/2018. BATCH QUANTITY WAS 768,000. PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. PRINT DEFECTS, INCLUDING JAMMED PART AT PRINTER WERE DOCUMENTED DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE AND PRODUCT WAS REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 8061823 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE DESCRIPTION: A PRINTING PROCESS ERROR POSSIBLY DUE TO A JAM. RATIONALE: CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEASURE MARKINGS ON SEVERAL BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WERE MISSING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499375 BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8061823 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other