BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE MICRO W/MICROGARD PST MTGN/AMB CE

    MDR report key: 8848860 · Received July 31, 2019

    Report

    Report Number
    2618282-2019-00231
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 7, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: TO DATE BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKS CAUSED BY A THINNER WALL AT THE BOTTOM OF THE TUBE WAS 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#766109 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND HAVE BEEN IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKS CAUSED BY A THINNER WALL AT THE BOTTOM OF THE TUBE WAS WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA#766109 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES HAVE BEEN IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA#766109 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 LEAKAGE OCCURRED DURING USE WITH A TUBE MICRO W/MICROGARD PST MTGN/AMB CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE IN MICROTAINER TUBES. SAME ISSUE AS DESCRIBED IN THE RECENT RECALL LETTER PAS.19-1454, BUT THIS IS A DIFFERENT LOT.NUMBER. THE LEAK IN THE TUBE WAS DETECTED WHEN THE TUBE WAS REMOVED FROM THE CENTRIFUGE. THIS MEANS THAT THE SAMPLE WAS NOT ANALYZED AND THAT THERE WAS BLOOD IN THE CENTRIFUGE THAT HAD TO BE CLEANED."

    Additional Manufacturer Narrative · 1

    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 LEAKAGE OCCURRED DURING USE WITH A TUBE MICRO W/MICROGARD PST MTGN/AMB CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE IN MICROTAINER TUBES. SAME ISSUE AS DESCRIBED IN THE RECENT RECALL LETTER PAS.19-1454, BUT THIS IS A DIFFERENT LOT NUMBER. THE LEAK IN THE TUBE WAS DETECTED WHEN THE TUBE WAS REMOVED FROM THE CENTRIFUGE. THIS MEANS THAT THE SAMPLE WAS NOT ANALYZED AND THAT THERE WAS BLOOD IN THE CENTRIFUGE THAT HAD TO BE CLEANED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640214 TUBE MICRO W/MICROGARD PST MTGN/AMB CE BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 830494N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other