BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 10350576 · Received July 31, 2020

    Report

    Report Number
    1917413-2020-00636
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 9, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 FORMATION/ RED BLOOD CELL CONTAMINATION WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER FORMATION/RBC CONTAMINATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETENTION LOT SAMPLES. EVALUATION OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE 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. BD WAS NOT ABLE TO IDENTIFIY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE IS POOR SEPARATOR MOVEMENT WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS RED BLOOD CELLS CONTAMINATING THE PBMC. I HAVE BEEN HAVING A RBC CONTAMINATION WHILE DOING PBMC ISOLATION. THE PATIENT SAMPLE IS DRAWN TO BD VACUTAINER® HEPARIN TUBES (GREEN CAP, ~10ML). THEN I TRANSFER IT TO THE BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM HEPARIN (362753). I AM DOING THE ISOLATION ACCORDING TO INSTRUCTION IN THE MANUAL. 1800 RCF, 23 MIN RT, BREAK OFF- FOR CPT. 300 RCF RT, 15 MIN BREAK ON WASH 1. 300 RCF 10 MIN BREAK ON WASH 2. BUT AFTER SECOND WASH I HAVE LOTS OF RBC IN THE PELLET. I CAN NOT EVEN SEE THE WHITE PELLET. AND I COULDN¿T GET RID OF THEM. NORMALLY IF I USE THIS CPT TUBES THERE IS NOT SUPPOSED TO BE RBC IN THE PBMC. DO YOU THINK CAN I USE RBD LYSES BUFFER AFTER WASH 2. SO I AM JUST WONDERING HOW CAN I GET RID OF THESE CELLS. COULD YOU PLEASE HELP ME ?

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9087908, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2019-03-28, MEDICAL DEVICE LOT #: 9240563, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2019-08-28." A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THERE IS POOR SEPARATOR MOVEMENT WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS RED BLOOD CELLS CONTAMINATING THE PBMC. I HAVE BEEN HAVING A RBC CONTAMINATION WHILE DOING PBMC ISOLATION. THE PATIENT SAMPLE IS DRAWN TO BD VACUTAINER® HEPARIN TUBES (GREEN CAP, 10 ML). THEN I TRANSFER IT TO THE BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE SODIUM HEPARIN (362753). I AM DOING THE ISOLATION ACCORDING TO INSTRUCTION IN THE MANUAL. 1800 RCF, 23 MIN RT, BREAK OFF FOR CPT, 300 RCF RT, 15 MIN BREAK ON WASH 1,300 RCF 10 MIN BREAK ON WASH 2, BUT AFTER SECOND WASH I HAVE LOTS OF RBC IN THE PELLET. I CAN NOT EVEN SEE THE WHITE PELLET. AND I COULDN T GET RID OF THEM. NORMALLY IF I USE THIS CPT TUBES THERE IS NOT SUPPOSED TO BE RBC IN THE PBMC. DO YOU THINK CAN I USE RBD LYSES BUFFER AFTER WASH 2? SO I AM JUST WONDERING HOW CAN I GET RID OF THESE CELLS. COULD YOU PLEASE HELP ME?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812703 BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362753 SEE H.10 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other