BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 11208576 · Received January 21, 2021

    Report

    Report Number
    9617032-2021-00061
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    December 30, 2020
    Report Date
    June 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D2: MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD). G2: MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD). H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367342, BATCH NO. UNKNOWN. IT IS REPORTED CUSTOMER EXPERIENCED A DIRTY NEEDLE STICK. PIR VERBIAGE RECEIVED, - "NSI ASSOCIATED WITH USE. NEEDLESTICK INJURY.""

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367342, BATCH NO. UNKNOWN. IT IS REPORTED CUSTOMER EXPERIENCED A DIRTY NEEDLE STICK. PIR VERBIAGE RECEIVED, "NSI ASSOCIATED WITH USE. NEEDLESTICK INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104021 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367342 UNKNOWN 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention