BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BBL¿ VENTING UNIT

    MDR report key: 7195416 · Received January 16, 2018

    Report

    Report Number
    1119779-2017-00012
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 9, 2017
    Report Date
    January 3, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JTA
    UDI-DI
    00382902710561
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT RETURNS, PHOTOS, OR CUSTOMER REPORTS WERE RECEIVED. TECH SERVICES HAS CONFIRMED: THE CUSTOMER WAS WEARING PPE (INCLUDING GLOVES) WHEN THE INCIDENT OCCURRED, RESULTS OF THE CUSTOMER¿S BASELINE TESTING IS UNKNOWN, AND THE CUSTOMER¿S INCIDENT ALIGNS WITH WHAT IS DEFINED AS AN S2 SEVERITY LEVEL FOR THIS PRODUCT (MATERIAL 271056). THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF QN TRENDS FOR THE BATCH. NO QNS WERE NOTED ON THE BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS EVENT TYPE (NEEDLE STICK). AN INSPECTION OF RETENTION SAMPLES FROM THE COMPLAINT BATCH (170401) DETERMINED THAT THE INCIDENT DID NOT OCCUR DUE TO PRODUCT DEFECT. THE RETENTION SAMPLE ALSO INDICATED THAT THIS PRODUCT WAS LABELED WITH REVISION 02 OF THE LABEL WHICH DOES NOT CONTAIN WARNINGS FOR THE USER. ALL BATCHES PRODUCED GOING FORWARD WILL BE LABELED WITH REVISION 03 OF THE LABEL THAT INCLUDES THE WARNINGS FOR THE USER. A CID MEETING WAS HELD (REFERENCE CID #(B)(4)) TO DETERMINE IF A CAPA WAS REQUIRED. BASED ON A REVIEW OF COMPLAINT TRENDS AND THE SEVERITY FOR THIS INCIDENT, NO FURTHER CORRECTIVE ACTION IS REQUIRED. INVESTIGATION CONCLUSION: NO PRODUCT RETURNS, PHOTOS, OR CUSTOMER REPORTS WERE RECEIVED. THIS COMPLAINT IS CONFIRMED BASED ON A REVIEW OF THE CURRENT LABELING AND CUSTOMER REPORT. BD ID/AST PLANT QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS MATERIAL AND INCIDENT. ROOT CAUSE DESCRIPTION: SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. HOWEVER, THERE WAS NO DEFECT IDENTIFIED WITH THE PRODUCT THAT WOULD HAVE CAUSED THIS EVENT. BASED ON THE EVALUATION OF SEVERITY AND OCCURRENCE OF THIS EVENT NO FURTHER CORRECTIVE ACTION IS REQUIRED. LABELING ON BATCHES GOING FORWARD WILL CONTAIN USER WARNINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A THE CUSTOMER STUCK THEMSELVES WHEN REMOVING THE VENT ON A BD BBL¿ VENTING UNIT. THE VENT HAS BEEN USED TO DISPENSE BLOOD ONTO PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36434 BD BBL¿ VENTING UNIT BLOOD CULTURE JTA BECTON, DICKINSON & CO. 170401 00382902710561

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention