BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 15572212 · Received October 10, 2022

    Report

    Report Number
    9617032-2022-01000
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    September 29, 2022
    Report Date
    February 17, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2123510. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2022-05-03. MEDICAL DEVICE LOT #: 2010179. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2022-01-10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER SEPARATION WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. THE SAMPLES DID NOT PRODUCE ANY INSTRUMENT ERRORS ON THE ROCHE COBAS PLATFORM AND WERE ABLE TO PRODUCE RESULTS VALIDATED FOR BOTH ACCURACY AND PRECISION. NO SURFACE DEPOSITS WERE DETECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER SEPARATION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES AUTOMATONS DETECT DEPOSITS ON THE SURFACE OF THE PLASMA AND THEREFORE DO NOT GIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿WE ARE EXPERIENCING HUGE PROBLEMS WITH OUR BARRICOR TUBES. THE ROCHE AUTOMATONS DETECT DEPOSITS ON THE SURFACE OF THE PLASMA AND THEREFORE DO NOT GIVE RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES AUTOMATONS DETECT DEPOSITS ON THE SURFACE OF THE PLASMA AND THEREFORE DO NOT GIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿WE ARE EXPERIENCING HUGE PROBLEMS WITH OUR BARRICOR TUBES. THE ROCHE AUTOMATONS DETECT DEPOSITS ON THE SURFACE OF THE PLASMA AND THEREFORE DO NOT GIVE RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888656 BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2010179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown