BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 10980375 · Received December 9, 2020

    Report

    Report Number
    9617032-2020-01028
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 20, 2020
    Report Date
    September 2, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: FUNCTIONAL TESTING WAS CONDUCTED ON RETENTION SAMPLES FROM MATERIAL #365053, LOT# 015156, 3.5ML BARRICOR TUBES. TESTING INCLUDED BLOOD DRAWN FROM SUBJECTS AND BAGGED BLOOD, NO ASPIRATION ERRORS WERE OBSERVED. FUNCTIONAL TESTING WAS CONDUCTED ON RETURNED SAMPLES, MATERIAL# 365056 LOT# 0311963, 5.5ML BARRICOR TUBES. DURING THIS TESTING BLOOD WAS DRAWN FROM SUBJECTS AND NO ASPIRATION ERRORS WERE DETECTED. IN ADDITION TO THE RETURNED SAMPLES RETENTION SAMPLES FROM MATERIAL# 365056 LOT# 0170952, 5.5 ML BARRICOR, AND MATERIAL# 365056 LOT# 0070862, 5.5 ML BARRICOR WERE TESTED USING FRESH AND BAGGED BLOOD. TWO SAMPLES FROM LOT# 0070862 HAD ASPIRATION ERRORS AND WERE OBSERVED TO HAVE MICRO-CLOTS POTENTIALLY FROM THE BAGGED BLOOD. THE ANALYTE PROBE WAS CLEAN AFTER THE RUN AND NO OTHER ASPIRATION ERRORS WERE OBSERVED. AFTER EXTENSIVE FUNCTIONAL TESTING, ANALYSIS OF AN ATELLICA INTERNAL SAMPLE PROBE, BD WAS NOT ABLE TO REPLICATE THE REPORTED FAILURE OR IDENTIFY ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INCIDENT LOT WAS CONDUCTED AND, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, CANNOT ASPIRATE FROM THE TUBE USING ANALYZER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: IN RECENT MONTHS THE CH HAS BEEN EQUIPPED WITH THE NEW ROBOTIC SIEMENS ATELLICA AND MANY PROBLEMS OF REJECTION OF TUBES ARE FOUND AROUND 20 TUBES A DAY THAT THEY ARE OBLIGED TO IRON MANUALLY WHILE THE TUBE IS WELL FILLED. THIS PROBLEM IS NOT ACCEPTABLE TO THE CH WHO ASKED SIEMENS TO REACT KNOWING THAT THE CH ABSOLUTELY DOES NOT WANT TO CHANGE THE TUBE AND TO GO BACK WITH THE TUBES PST.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, CANNOT ASPIRATE FROM THE TUBE USING ANALYZER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IN RECENT MONTHS THE CH HAS BEEN EQUIPPED WITH THE NEW ROBOTIC SIEMENS ATELLICA AND MANY PROBLEMS OF REJECTION OF TUBES ARE FOUND AROUND 20 TUBES A DAY THAT THEY ARE OBLIGED TO IRON MANUALLY WHILE THE TUBE IS WELL FILLED. THIS PROBLEM IS NOT ACCEPTABLE TO THE CH WHO ASKED SIEMENS TO REACT KNOWING THAT THE CH ABSOLUTELY DOES NOT WANT TO CHANGE THE TUBE AND TO GO BACK WITH THE TUBES PST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439313 BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1