BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 11509450 · Received March 17, 2021

    Report

    Report Number
    9617032-2021-00229
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 0175694. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2020-06-23. MEDICAL DEVICE LOT #: 0240233. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2020-08-27. MEDICAL DEVICE LOT #: 0308003. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2020-11-03. MEDICAL DEVICE LOT #: 0356145. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. DEVICE MANUFACTURE DATE: 2020-12-21. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 · 1

    IT WAS REPORTED THAT 4 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES OVERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VACUUM SYSTEM DOES NOT SEEM TO WORK WELL, SINCE IT DOES NOT STOP AT THE MARK AS IT DID BEFORE AND AS OTHER TUBES OF YOURS DO, SUCH AS THOSE OF EDTA, BUT THEY ARE FILLED WITH BLOOD UP TO THE STOPPER, WHICH CAUSES THAT WHEN WE CENTRIFUGE THEM THE PLASMA ALSO THIS PAST OF THE MARK AND WE BELIEVE THAT THIS IS WHAT IS CAUSING US THAT THE VALUES OF THE TP ARE LOWER THAN NORMAL I LEAVE YOU HERE THE LIST OF ALL THE BATCHES THAT WE HAVE TESTED AND I ATTACH A PHOTO OF A CENTRIFUGED CITRATE TUBE AND ANOTHER WITHOUT CENTRIFUGATION SO THAT YOU CAN SEE WHAT I MEAN. CITRATE TUBES ((B)(4)): ¿ LOT 0175694 ¿ LOT 0240233 ¿ LOT 0308003 ¿ LOT 0356145 WE LOOK FORWARD TO YOUR RESPONSE AS SOON AS POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406366 BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1