BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 10976877 · Received December 9, 2020

    Report

    Report Number
    9617032-2020-01011
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-12-16. INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR TUBE PUSH OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO TUBE PUSH OFF 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 THE BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN WE PUSH THE TUBE INTO THE HOLDER AND IT IS PIERCED BY THE NEEDLE (BLOOD FLOWS INTO THE TUBE), WE MUST ABSOLUTELY KEEP THE TUBE PRESSED WITH YOUR THUMB. IF WE DON'T, THE TUBE POPS OUT OF THE NEEDLE AND HOLDER IN A TOTALLY RANDOM FASHION.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0240243, MEDICAL DEVICE EXPIRATION DATE:2021-12-31, DEVICE MANUFACTURE DATE: 2020-08-27. MEDICAL DEVICE LOT #: 0230279, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2020-08-17. 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 BD VACUTAINER(R) K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN WE PUSH THE TUBE INTO THE HOLDER AND IT IS PIERCED BY THE NEEDLE (BLOOD FLOWS INTO THE TUBE), WE MUST ABSOLUTELY KEEP THE TUBE PRESSED WITH YOUR THUMB. IF WE DON'T, THE TUBE POPS OUT OF THE NEEDLE AND HOLDER IN A TOTALLY RANDOM FASHION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443151 BD VACUTAINER K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 368861 SEE H.10 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1