BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7342225 · Received March 15, 2018

    Report

    Report Number
    1213809-2018-00171
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 7, 2018
    Report Date
    June 25, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: 2 DIFFERENT LOT NUMBERS WERE REPORTED IN THIS COMPLAINT. LOT # 8001759, EXPIRATION DATE 12/31/2022, MANUFACTURE DATE 01/01/2018. LOT # 8020529, EXPIRATION DATE 12/31/2022, MANUFACTURE DATE 01/20/2018. INVESTIGATION RESULTS: 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. DHR REVIEW FOR BATCH 8001759 (P/N 301073): MANUFACTURING DATES: 01/02/2018 TO 01/03/2018. BATCH QUANTITY WAS 576,000. ASSEMBLY 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 8001759 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 8020529 (P/N 301073): MANUFACTURING DATES: 01/22/2018 TO 01/23/2018. BATCH QUANTITY WAS 768,000. PRINTING AND ASSEMBLY 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 8020529 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN RECEIVED FOR EVALUATION. INVESTIGATION SUMMARY: THREE LOOSE 3ML SYRINGES WERE RECEIVED IN A POUCH LABELED LOT# 8020529 (P/N 301073). TWO SYRINGES WERE FOUND TO HAVE DAMAGE TO THE BARREL IN A FORM OF SCRATCH MARKS EXTENDING APPROXIMATELY 2 - 2.5 CM FROM THE BOTTOM OF THE BARREL (ZERO LINE). ON ONE OF THESE SYRINGES THE DAMAGE GOES OVER THE PRINT MARKINGS YET THE PRINT IS UNAFFECTED INDICATING THE DAMAGE HAPPENED PRIOR TO THE PRINTING PROCESS. THE SAMPLES WERE EVALUATED. ONE SYRINGE WAS FOUND TO HAVE SEVERAL BLACK SPOTS EMBEDDED IN THE PLASTIC OF THE BARREL. THE BLACK SPOTS ARE MOST LIKELY BURNT PLASTIC. THEY ARE LESS THAN LEVEL 3 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION AND ARE CONSIDERED A COSMETIC DEFECT. BASED ON THE EVALUATION PERFORMED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE FOR LOT #8020529 AND DEFECT: DAMAGED BARRELS. THE DAMAGE TO THE BARREL LIKELY OCCURRED FROM BARRELS TEMPORARILY GETTING JAMMED AGAINST METALING TOOLING WHILE BEING TRANSFER FROM MOLDING TO THE MARKER. THE DEFECT IS CONSIDERED ISOLATED TO A FEW UNITS BASED ON THE INVESTIGATION PERFORMED AND ON THE COMPLAINT HISTORY CHECK. HOWEVER, BD WAS UNABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION FOR LOT # 8001759. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED BATCH. CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE BD LUER-LOK¿ SYRINGE WAS FOUND BROKEN AS THERE WAS AN ¿ABSENCE OF TIP ON SEVERAL STERILE SYRINGES. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183484 BD LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other