BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 16865100 · Received May 3, 2023

    Report

    Report Number
    9617032-2023-00511
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 25, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.4 INITIAL REPORTER PHONE #: (B)(6). H.6 INVESTIGATION SUMMARY: MATERIAL #: 364314. LOT/BATCH #: 2130908. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO LOOSE CANNULA 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE LOOSE CANNULA. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE THAT THE ARTERIAL BLOOD GAS NEEDLE WAS LOOSE (THE BLOOD COLLECTION DEVICE WAS TIGHTENED BEFORE DRAWING BLOOD), AND THE PATIENT'S ARTERIAL BLOOD GUSHED OUT AND POLLUTED THE NURSE'S LEFT HAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AT AROUND 22:45 ON (B)(6) 2023, WHEN COLLECTING ARTERIAL BLOOD GAS FOR EMERGENCY PATIENTS IN THE WARD, THE ARTERIAL BLOOD GAS NEEDLE WAS LOOSE (THE BLOOD COLLECTION DEVICE WAS TIGHTENED BEFORE DRAWING BLOOD), AND THE PATIENT'S ARTERIAL BLOOD GUSHED OUT AND POLLUTED THE NURSE'S LEFT HAND. THE THUMB IS CONTAMINATED. WHEN THE RIGHT HAND TWISTS THE BLOOD GAS NEEDLE COVER, IT MAY BE CONTAMINATED BY BLOOD TO THE WOUND ON THE RIGHT HAND (THE WOUND ON THE RIGHT HAND IS A NEW WOUND THAT WAS CUT AT 20:00 ON (B)(6)2023). AFTER TIGHTENING THE COVER, RETURN TO THE BACK OF THE NURSE'S STATION IMMEDIATELY. RINSE UNDER RUNNING WATER (ABOUT 22:50), AND DISINFECT WITH POVIDONE IODINE AFTER RINSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543984 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2130908

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown