BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBE MEDIA TUBE LIHEP PLH

    MDR report key: 8181496 · Received December 19, 2018

    Report

    Report Number
    9617032-2018-03211
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 28, 2018
    Report Date
    February 28, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT "A LOT" OF BD¿ TUBE MEDIA TUBE LIHEP PLH WERE UNDERFILLING, ROUGHLY 100. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: A CAPA WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A LOT" OF BD¿ TUBE MEDIA TUBE LIHEP PLH WERE UNDERFILLING, ROUGHLY 100.

    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 BD¿ TUBE MEDIA TUBE LIHEP PLH WERE UNDERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017531 BD¿ TUBE MEDIA TUBE LIHEP PLH BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 8151678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other