BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7510726 · Received May 14, 2018

    Report

    Report Number
    1213809-2018-00278
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD RECEIVED TOTAL OF 347 LOOSE 10ML SYRINGES CONFIRMED TO BE FROM BATCH # 8001668 (P/N 309605). THE SAMPLES WERE VISUALLY EVALUATED. ALL SAMPLES WERE CHECKED, 80 SYRINGES HAD ACCEPTABLE PRINT QUALITY; HOWEVER, 267 SYRINGES WERE FOUND TO HAVE ILLEGIBLE PRINT BETWEEN 3ML AND 4ML GRAD LINES, WHICH IS A REJECTABLE CONDITION. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH. PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. 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: SAMPLE EVALUATION: 2 BOXES WERE RECEIVED, CONTAINING TOTAL 347 LOOSE 10ML SYRINGES IN SEPARATED BAGS. ONE BOX HAD 1 BAG. ONE BOX HAD 5 BAGS, WITH 3 OF THE BAGS CONTAINING TOP WEB OF A 10ML SYRINGE TRAY, CONFIRMED TO BE FROM BATCH # 8001668 (P/N 309605). THE SAMPLES WERE VISUALLY EVALUATED. ALL SAMPLES WERE CHECKED. 80 SYRINGES HAD ACCEPTABLE PRINT QUALITY. 267 SYRINGES WERE FOUND TO HAVE ILLEGIBLE PRINT BETWEEN 3ML AND 4ML GRAD LINES, WHICH IS A REJECTABLE CONDITION. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. DHR REVIEW FOR BATCH #8001668 (P/N 309605): MANUFACTURING DATES: 12/20/2017 TO 01/09/2018. BATCH QUANTITY WAS 172,800. PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8001668 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE DESCRIPTION: BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD SMEARED GRADUATION MARKS BETWEEN THE NUMBERS, 3 AND 5 WAS FOUND ON THE 10ML BD SYRINGES. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355770 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001668 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other