BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 8780381 · Received July 11, 2019

    Report

    Report Number
    1416980-2019-03716
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 13, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    UDI-DI
    00085412048994
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MFR LOCATION/SITE: PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE (B)(4). CATALOGUE # PREVIOUSLY SUBMITTED AS 2C8519. LOT # PREVIOUSLY SUBMITTED AS R19C27055. CORRECTED TO UNKNOWN. UDI # PREVIOUSLY SUBMITTED AS (B)(4). CORRECTED TO NI. PMA/510K# (PREVIOUSLY SUBMITTED AS K961225). THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE RECEIVED WAS A DIFFERENT PRODUCT THEN THE PRODUCT CODE INITIALLY REPORTED AND THEREFORE, CORRECTED INFORMATION HAS BEEN ADDED. A VISUAL INSPECTION VIA THE NAKED EYE WAS DONE WHICH OBSERVED A SHALLOW INSERTION ON THE TUBING TO THE TWO PIECE LUER LOCK JOINT OF THE SUB-ASSEMBLY. A FUNCTIONAL UNDER WATER PRESSURE TEST WAS PERFORMED WHICH REVEALED LEAKAGE FROM THE TUBING JOINT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION WAS A MANUFACTURING ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED AT ¿ONE OF THE JUNCTURES BETWEEN THE LUER LOCK AND THE TUBING¿ (NOT FURTHER SPECIFIED). THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THE DEVICE WAS BEING USED TO DELIVER AN INTRAOSSEOUS (IO) INFUSION OF LEVOPHED TO THE PATIENT. TO REMEDY THE ISSUE, THE SET UP WAS CHANGED AND A NEW BAG WAS HUNG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574279 DUO-VENT CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE NA R19C27055 00085412048994

    Patients

    Seq Age Sex Outcome Treatment
    1 LEVOPHED| LEVOPHED