BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7359328 · Received March 21, 2018

    Report

    Report Number
    1213809-2018-00188
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 16, 2018
    Report Date
    April 20, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS WERE REPORTED FOR THIS COMPLAINT. MEDICAL DEVICE LOT NUMBER: 5240590. MEDICAL DEVICE EXPIRATION DATE: 08/31/2020. DEVICE MANUFACTURE DATE: 10/10/2015. MEDICAL DEVICE LOT NUMBER: 5315722. MEDICAL DEVICE EXPIRATION DATE: 10/31/2020. DEVICE MANUFACTURE DATE: 11/20/2015. INVESTIGATION SUMMARY: PHOTO EVALUATION: NO PHYSICAL SAMPLE WAS RECEIVED, 3 PHOTOS WERE RECEIVED AND EVALUATED. PRODUCT REPORTED TO BE FROM BATCH #5240590 OR #5315722. A SINGLE SYRINGE WAS DEPICTED IN EACH OF THE 3 PHOTOS WITH A LABEL ATTACHED AND FILLED WITH LIGHT COLORED FLUID. FLUID WAS OBSERVED ON THE FLANGE OF A SYRINGE IN ONE PHOTO. FLUID BEYOND THE STOPPER WAS OBSERVED IN OTHER PHOTOS. LEAKAGE PAST STOPPER IS A REJECTABLE CONDITION. DHR REVIEW FOR BATCH 5240590 (P/N 301029): MANUFACTURING DATES: 09/30/2015 TO 10/06/2015. BATCH QUANTITY WAS (B)(4). 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 5240590 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 5315722 (P/N 301029): MANUFACTURING DATES: 11/18/2015 TO 11/20/2015. BATCH QUANTITY WAS (B)(4). 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 5315722 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PRODUCT DEFECT CONFIRMED BASED ON PHOTO EVALUATION. ROOT CAUSE AND 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD SYRINGE LUER-LOK¿ TIP WAS FOUND LEAKING AS THE FLUID DRIPPED OUT OF THE SYRINGE BARREL. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201816 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other