BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 11166840 · Received January 13, 2021

    Report

    Report Number
    3003916417-2021-00007
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 23, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "SOME TUBES OF BD 5ML SERUM GEL DO NOT HAVE ENOUGH VACUUM FOR ADEQUATE BLOOD ASPIRATION, INCLUDING BEING FORCED TO A NEW PUNCTURE AND LEAVING PATIENTS DISSATISFIED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0060350, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0111086, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2020-06-10. 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 THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "SOME TUBES OF BD 5ML SERUM GEL DO NOT HAVE ENOUGH VACUUM FOR ADEQUATE BLOOD ASPIRATION, INCLUDING BEING FORCED TO A NEW PUNCTURE AND LEAVING PATIENTS DISSATISFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64563 TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1