BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 10428969 · Received August 19, 2020

    Report

    Report Number
    9617032-2020-00666
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 31, 2020
    Report Date
    January 11, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD DID NOT RECEIVE SAMPLES BUT ONE PHOTO WAS PROVIDED FOR REVIEW. THE LOT NUMBER OF THE TUBES WAS NOT PROVIDED. THEREFORE, A COMPLAINT HISTORY REVIEW AND DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. THE COMPLAINT IS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT, HOWEVER IT IS UNDERSTOOD THAT PATIENT CONDITIONS AND PROCESSING FACTORS CAN IMPACT ON THE QUALITY OF THE BARRIER OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS POOR SEPARATOR MOVEMENT AND THE INSTRUMENT PROBES ARE CLOGGING DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE A PROBLEM WITH THESE TUBES: IN SOME CASES THE GEL SEPARATOR IS PLACED ABOVE THE SERUM AFTER CENTRIFUGATION. THIS PROBLEM IS EXTREMELY WORRYING BECAUSE IT BLOCKS OUR LINE BY CLOGGING OUR SAMPLING PROBES. THIS PROBLEM SEEMS TO AFFECT ONLY SAMPLES TAKEN IN DIALYSIS DEPARTMENTS. ADDITIONALLY, ON 2020-08-13 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WOULD YOU LIKE TO SEND US A FEW UNITS OF THESE BATCHES FOR ANALYSIS? IT IS NOT NECESSARY BECAUSE IT SEEMS THAT THE DIALYSIS KT SOLUTION IS INCRIMINATED. PLEASE PROVIDE US WITH DETAILS ON THE STORAGE OF THESE TUBES? THE TUBES ARE STORED AT CONTROLLED ROOM TEMPERATURE. WHAT ACTIONS HAVE BEEN TAKEN FOLLOWING THIS INCIDENT REMINDER OF SAMPLING PROTOCOLS TO THE DIALYSIS CENTRE NURSES TO AVOID CONTAMINATION OF SAMPLES WITH KTC SOLUTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THERE IS POOR SEPARATOR MOVEMENT AND THE INSTRUMENT PROBES ARE CLOGGING DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE A PROBLEM WITH THESE TUBES: IN SOME CASES THE GEL SEPARATOR IS PLACED ABOVE THE SERUM AFTER CENTRIFUGATION. THIS PROBLEM IS EXTREMELY WORRYING BECAUSE IT BLOCKS OUR LINE BY CLOGGING OUR SAMPLING PROBES. THIS PROBLEM SEEMS TO AFFECT ONLY SAMPLES TAKEN IN DIALYSIS DEPARTMENTS. ADDITIONALLY, ON 2020-08-13 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WOULD YOU LIKE TO SEND US A FEW UNITS OF THESE BATCHES FOR ANALYSIS? IT IS NOT NECESSARY BECAUSE IT SEEMS THAT THE DIALYSIS KT SOLUTION IS INCRIMINATED. PLEASE PROVIDE US WITH DETAILS ON THE STORAGE OF THESE TUBES? THE TUBES ARE STORED AT CONTROLLED ROOM TEMPERATURE. WHAT ACTIONS HAVE BEEN TAKEN FOLLOWING THIS INCIDENT: REMINDER OF SAMPLING PROTOCOLS TO THE DIALYSIS CENTRE NURSES TO AVOID CONTAMINATION OF SAMPLES WITH KTC SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889545 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367957 UNKNOWN 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other