BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR LUER LOCK C35

    MDR report key: 8916009 · Received August 21, 2019

    Report

    Report Number
    3003152976-2019-00572
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 4, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152000
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NINETEEN SAMPLES FROM CONNECTOR LOT 1905112 WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, ENGAGING AND DISENGAGING THE CONNECTORS AND RETAINED SAMPLE INJECTORS FROM LOT 1905109. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. RETAINED SAMPLES FROM BOTH LOTS 1905112 AND 1903108 WERE USED FOR ADDITIONAL EVALUATION. NO DEFECTS WERE IDENTIFIED WHEN THE PRODUCT WAS INSPECTED AND THERE WAS NO ISSUES OBSERVED WHEN ENGAGING AND DISENGAGING THE CONNECTORS FROM SAMPLES OF INJECTOR LOT 1905109. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. IN ALL CASES THE PRODUCT PERFORMED AS INTENDED, THERE WAS NO ISSUES NOTED IN ANY OF THE TESTING RELATED TO THE CONNECTION OR DISCONNECTION OF THE DEVICE. DHR REVIEW AND LOT RELEASE TESTING DO NOT INDICATE ANY ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE CONNECTOR LUER LOCK C35 HAS BEEN FOUND EXPERIENCING CONNECTION ISSUES BETWEEN THE CONNECTOR AND LUER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE GOT AN INJECTOR + CONNECTOR BACK FROM A NURSE FROM AN MTX SYRINGE. THE CONNECTOR DOES NOT FIT THE INJECTOR. I GOT BOTH PRODUCTS BACK AND INDEED THEY DON'T FIT TOGETHER. IT WOULD BE THE SECOND TIME THAT THE NURSE HAS DONE THIS. OUR CURRENT LOT NUMBERS ARE: CONNECTOR: 1903108 - 1812112 - 1905112, INJECTOR WITH CAP: 1905109.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905112. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2019-05-29. MEDICAL DEVICE LOT #: 1903108. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2019-03-29. MEDICAL DEVICE LOT #: 1812102. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2018-12-13 . A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CONNECTOR LUER LOCK C35 HAS BEEN FOUND EXPERIENCING CONNECTION ISSUES BETWEEN THE CONNECTOR AND LUER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE GOT AN INJECTOR + CONNECTOR BACK FROM A NURSE FROM AN MTX SYRINGE. THE CONNECTOR DOES NOT FIT THE INJECTOR. I GOT BOTH PRODUCTS BACK AND INDEED THEY DON'T FIT TOGETHER. IT WOULD BE THE SECOND TIME THAT THE NURSE HAS DONE THIS. OUR CURRENT LOT NUMBERS ARE: CONNECTOR: 1903108 - 1812112 - 1905112. .INJECTOR WITH CAP: 1905109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712413 CONNECTOR LUER LOCK C35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE H.10 30382905152000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other