BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 7492261 · Received May 7, 2018

    Report

    Report Number
    2618282-2018-00358
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    May 12, 2017
    Report Date
    March 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MFR REPORT #: 1917413-2018-01285 HAS BEEN CHANGED TO THE INITIAL MDR SUBMISSION OF 2618282-2018-00358. THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D1: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. D2: MEDICAL DEVICE TYPE: ORIGINAL ENTRY: JKA. D4: UNIQUE IDENTIFIER (UDI) #: (B)(4). G5: PMA/510(K) #: K972075.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD AIR BUBBLES IN THE GEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA 5.4MG TUBES HAD AIR BUBBLES IN THE GEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332141 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6253974

    Patients

    Seq Age Sex Outcome Treatment
    1 Other