BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE

    MDR report key: 6202522 · Received December 23, 2016

    Report

    Report Number
    9617032-2016-00007
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    October 30, 2016
    Report Date
    May 13, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Removal / Correction Number
    PAS-18-1175-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BD IS ISSUING A VOLUNTARY MEDICAL DEVICE CORRECTION FOR BD VACUTAINER® PLASTIC LITHIUM HEPARIN TUBES. FALSE ELEVATION OF CARBOXYHEMOGLOBIN (COHB) RESULTS HAVE BEEN REPORTED WHEN ANALYZING VENOUS BLOOD SAMPLES COLLECTED WITH BD VACUTAINER® PLASTIC LITHIUM HEPARIN TUBES WITH THE IL GEM 4000 INSTRUMENT. PLEASE REFERENCE BD RECALL #: PAS-18-1175-FA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING A 13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE. A PATIENT'S CARBOXYHEMOGLOBIN RESULTS CAME BACK BETWEEN 6 AND 7.5%. THIS RESULTED IN THE PATIENT'S EXTENDED HOSPITALIZATION IN AN EMERGENCY DEPARTMENT FOR EIGHT HOURS AND OXYGEN THERAPY TREATMENT.

    Additional Manufacturer Narrative · 1

    RESULTS: IN ADDITION TO THE NO SAMPLE INVESTIGATION THAT WAS PREVIOUSLY REPORTED, A MANUFACTURING REVIEW (PREVENTATIVE MAINTENANCE AND CALIBRATION) WAS ALSO COMPLETED ON 1/27/2017. PREVENTATIVE MAINTENANCE OF THE MANUFACTURING EQUIPMENT USED IN THE PRODUCTION OF THESE TUBES WERE REVIEWED AND WERE FOUND TO BE IN COMPLIANCE TO THE PM SCHEDULE. NO ISSUES HAVE BEEN IDENTIFIED AND THERE WERE NO DEVIATIONS RAISED FOR MISSED PM ACTIVITIES. ALL EQUIPMENT ASSOCIATED WITH THE MANUFACTURING AND TESTING OF THIS PRODUCT WAS REVIEWED AND WAS FOUND TO BE WITHIN CALIBRATION. NO MISSING OR OOT EQUIPMENT WAS IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AFTER SUBMITTING THE INITIAL MDR, THE CUSTOMER PROVIDED A LOT # FOR THIS INCIDENT. THE INFORMATION FOR THE LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6238723. MEDICAL DEVICE EXPIRATION DATE: 2/28/2018. DEVICE MANUFACTURE DATE: 8/25/2016. DEVICE EVALUATION: RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6238723 AND NO NCMRS WERE IN FORCE FOR THE IMPLICATED MATERIALS. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT NO OBJECTIVE EVIDENCE WAS PROVIDED BY THE CUSTOMER THE DEPTH OFF THE INVESTIGATION WAS LIMITED. THE REVIEW OF THE DHR IDENTIFIED NO ISSUES RELATING TO THE REPORTED DEFECT. FURTHER INVESTIGATION IDENTIFIED THAT THE CUSTOMER HAD RECENTLY CONVERTED FROM A COMPETITOR TUBE, WHICH THEY USED TO DETERMINE HBCO VALUES, BUT HAD FAILED TO VALIDATE THE APPROPRIATENESS OF THE BD TUBES. BD DOES NOT RECOMMEND THE USE OF PSTII TUBES FOR THIS DETERMINATION AND WOULD ONLY SPECIFY ABG PRODUCTS. INAPPROPRIATE DEVICE USED FOR DETERMINATION OF HBCO AND LACK OF VALIDATION OF THE METHOD LEAD TO ERRONEOUS RESULTS BEING OBTAINED. ADDITIONALLY, A PREVENTATIVE MAINTENANCE/CALIBRATION RECORD REVIEW WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, A SECOND SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING A 13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE. A PATIENT'S CARBOXYHEMOGLOBIN RESULTS CAME BACK BETWEEN 6 AND 7.5%. THIS RESULTED IN THE PATIENT'S EXTENDED HOSPITALIZATION IN AN EMERGENCY DEPARTMENT FOR EIGHT HOURS AND OXYGEN THERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853425 13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6238723

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R