BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE GLU PLH 13X75 2.0 PLBL L/GR

    MDR report key: 8348482 · Received February 18, 2019

    Report

    Report Number
    1917413-2019-00268
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 28, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903675871
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INSUFFICIENT ADDITIVE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE ISSUE RELATING TO MISSING ADDITIVE 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 FOR INSUFFICIENT ADDITIVE WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND MISSING ADDITIVE WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBE GLU PLH 13X75 2.0 PLBL L/GR DID NOT HAVE PRESERVATIVE/ADDITIVE. THIS OCCURRED ON 300 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (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 TUBE GLU PLH 13X75 2.0 PLBL L/GR DID NOT HAVE PRESERVATIVE/ADDITIVE. THIS OCCURRED ON 300 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139921 TUBE GLU PLH 13X75 2.0 PLBL L/GR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 8187669 50382903675871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other