BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ADAPTER WITH LUER ADAPTER

    MDR report key: 8210100 · Received January 2, 2019

    Report

    Report Number
    1024879-2018-01541
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 12, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K921520
    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: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONALLY, THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® ADAPTER WITH LUER ADAPTER HAD ISSUES WITH "THICKENING WHERE THE RUBBER OF THE TUBE NEEDLE IS ATTACHED TO THE LUER ADAPTOR SCREW".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8214977. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-08-02. MEDICAL DEVICE LOT #: 8047676. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-02-16. MEDICAL DEVICE LOT #: 6245900. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2016-09-01. MEDICAL DEVICE LOT #: 7282714. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-09. MEDICAL DEVICE LOT #: 7356860. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2017-12-22. MEDICAL DEVICE LOT #: 8150679. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2018-05-30. MEDICAL DEVICE LOT #: 8235658. MEDICAL DEVICE EXPIRATION DATE: 8235658. DEVICE MANUFACTURE DATE: 2018-08-23. (B)(6). 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 THE BD VACUTAINER® ADAPTER WITH LUER ADAPTER HAD ISSUES WITH "THICKENING WHERE THE RUBBER OF THE TUBE NEEDLE IS ATTACHED TO THE LUER ADAPTOR SCREW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3836 BD VACUTAINER® ADAPTER WITH LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other