BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7331533 · Received March 12, 2018

    Report

    Report Number
    1213809-2018-00102
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 17, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THREE SEALED 5ML SYRINGE CONVENIENCE TRAYS FROM LOT #7240846, P/N 309703 WERE RECEIVED AND EVALUATED. NO SAMPLES WERE RECEIVED FROM LOTS 7208594 AND 7208590. ALSO THREE SEALED 5ML SYRINGE CONVENIENCE TRAYS FROM LOT #7299678, P/N 309703 WERE ALSO RECEIVED AND EVALUATED. ALL 150 SYRINGES FROM THESE TRAYS WERE TESTED FOR LEAKAGE PAST STOPPER ACCORDING TO OUR TEST PROCEDURE. ALL 150 SYRINGES PASSED THE TEST WITH NO LEAKAGE PAST FIRST NOR SECOND RIB OBSERVED. BASED ON THE RESULTS OF THE TESTING, THE PRODUCT DEFECT COULD NOT BE CONFIRMED. DHR REVIEW FOR BATCH 7299678 (P/N 309703): MANUFACTURING DATE 11/04/2017 ¿ 11/15/2017 BATCH SIZE WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7299678 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7240846 (P/N 309703): MANUFACTURING DATES FOR BATCH: 09/24/2017 ¿ 09/26/2017, BATCH SIZE WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7240846 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT DHR REVIEW FOR BATCH 7208594 (P/N 309703): MANUFACTURING DATES: 8/20/2017 ¿ 8/21/2017, BATCH SIZE WAS (B)(4) PIECES. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7208594 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7208590 (P/N 309703): MANUFACTURING DATES: 8/15/2017 ¿ 8/16/2017, BATCH SIZE WAS (B)(4) PIECES. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7208590 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REVIEW FOR ALL FOUR LOTS SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE EVALUATION PERFORMED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE AND CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. 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. NOTE: PRODUCT LOTS RECEIVED DID NOT ALL MATCH THOSE LISTED IN EVENT DESCRIPTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7240846; MEDICAL DEVICE EXPIRATION DATE: 2022-08-31; DEVICE MANUFACTURE DATE: 2017-10-03. MEDICAL DEVICE LOT #: 7208590; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-08-21. MEDICAL DEVICE LOT #: 7208594; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-09-01. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SIGNIFICANT NUMBER OF BD LUER-LOK¿ SYRINGE(S) IN A BULK STERILE PHARMACY CONVENIENCE TRAY HAVE BEEN ¿LEAKY¿. CUSTOMER STATES THAT ONCE THE SYRINGE IS FILLED, THERE IS VISIBLE FLUID BETWEEN THE TWO RIBS OF THE BLACK RUBBER PLUNGER AND FLUID BEYOND THE SECOND RIB (BEYOND THE RUBBER PLUNGER). THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175612 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other