BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 18941160 · Received March 20, 2024

    Report

    Report Number
    2243072-2024-00306
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 15, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    30382903672838
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5: EVENT DESCRIPTION. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE WINGSET WAS NOT DRAWING BLOOD CORRECTLY. THE USER EXPERIENCED A FLOW ISSUE AND BLOOD SPLATTERED AS IF THERE WAS NO TOP ON THE DEVICE. THE BLOOD SPLATTERED ON THE PATIENT AND CHAIR, BUT NO EXPOSURE TO THE USER WAS REPORTED. H.6 INVESTIGATION SUMMARY . MATERIAL #: 367283. LOT/BATCH #: UNKNOWN. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NIPRO. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER PMA / 510(K)#: K980414 , K991088 MEDICAL DEVICE LOT #: UNKNOWN MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT THE WINGSET WAS NOT DRAWING BLOOD CORRECTLY. THE USER EXPERIENCED A FLOW ISSUE AND BLOOD SPLATTERED AS IF THERE WAS NO TOP ON THE DEVICE. THE BLOOD SPLATTERED ON THE PATIENT AND CHAIR, BUT NO EXPOSURE TO THE USER WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT WINGSETS NOT DRAWING BLOOD CORRECTLY. BLOOD SPLATTERS EVERYWHERE ALMOST AS IF IT HAS NO TOP ON IT AT ALL. STAFF WAS EXPOSED TO BLOOD BUT THERE WAS NO REPORT OF ADVERSE MEDICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436613 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN 30382903672838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown