BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 10214985 · Received June 30, 2020

    Report

    Report Number
    9617032-2020-00536
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    May 26, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 20 RETAINED SAMPLES WERE DRAW-TESTED FROM BATCH 9162533 AND 20 TUBES FROM BATCH 9259608 WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 365056, BATCH NO. 9162533 AND 9259608. COMPLAINT 2 OF 3. IT IS REPORTED BY CUSTOMER THAT BARRICOR TUBES ARE NOT FILLING. IS THE PRODUCT/CATALOG NUMBER KNOWN? 365056. IS THE LOT NUMBER OF THE TUBES THAT WERE AFFECTED KNOWN? 9162533 AND 9259608. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? IF UNKNOWN, STATE N/A. (B)(6) 2020. WERE THERE ANY ERRONEOUS RESULTS REPORTED? IF SO, NO. ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) MALE PATIENT, 57. WHAT TEST(S) WERE RUN? WE USE BARRICOR TUBES FOR TROPONIN ONLY WAS THE PATIENT REDRAWN AND RE TESTED? YES.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: ONLY THAT PATIENT'S AGE WAS PROVIDED THEREFORE A DEFAULT DATE OF BIRTH HAS BEEN LISTED (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9162533, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2019-06-11, MEDICAL DEVICE LOT #: 9259608, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2019-09-16.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 365056 BATCH NO. 9162533 AND 9259608. COMPLAINT 2 OF 3. IT IS REPORTED BY CUSTOMER THAT BARRICOR TUBES ARE NOT FILLING. IS THE PRODUCT/CATALOG NUMBER KNOWN? 365056. IS THE LOT NUMBER OF THE TUBES THAT WERE AFFECTED KNOWN? 9162533 AND 9259608. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? IF UNKNOWN, STATE N/A. (B)(6) 2020. WERE THERE ANY ERRONEOUS RESULTS REPORTED? IF SO, NO. ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) MALE PATIENT, (B)(6). WHAT TEST(S) WERE RUN? WE USE BARRICOR TUBES FOR TROPONIN ONLY. WAS THE PATIENT REDRAWN AND RE TESTED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679603 BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other