BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 10202347 · Received June 26, 2020

    Report

    Report Number
    9617032-2020-00522
    Event Type
    Malfunction
    Date Received
    June 26, 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. 20 RETAINED SAMPLES (LOT 9162533) AND 20 RETAINED SAMPLES (LOT 9259608) WERE DRAW-TESTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBES ARE UNDER FILLING DURING USE WITH A BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS). IT IS REPORTED BY CUSTOMER THAT BARRICOR TUBES ARE NOT FILLING. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿ 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. O ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) 3 MALE PATIENTS (AGES: 62, 57, 92); O WHAT TEST(S) WERE RUN? WE USE BARRICOR TUBES FOR TROPONIN ONLY; O WAS THE PATIENT REDRAWN AND RE TESTED? YES.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6) 1928 WAS USED AS PLACEHOLDER AS AGE WAS PROVIDED, NOT PATIENT BIRTHDAY. "MULTIPLE LOT NUMBERS: 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. " 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 THE TUBES ARE UNDER FILLING DURING USE WITH A BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) IT IS REPORTED BY CUSTOMER THAT BARRICOR TUBES ARE NOT FILLING. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 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.) 3 MALE PATIENTS (AGES: 62, 57, 92). 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
    667827 BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other