BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING SET

    MDR report key: 11680600 · Received April 16, 2021

    Report

    Report Number
    2243072-2021-01185
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    December 22, 2020
    Report Date
    May 17, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: CATALOG # 2426-0007. D4: UDI # (B)(4). G.5. PMA / 510(K)# K944320. H6: INVESTIGATION SUMMARY: ONE PRIMARY SET (MODEL # 2426-0007) AND A NON-BD SECONDARY SET WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THERE WAS A SUSPECTED BACK-CHECK VALVE FAILURE. THE SAMPLES WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY USING A PRIMARY BAG FILLED WITH CLEAR SALINE WHICH WAS THEN USED TO PRIME THE SET. FOR TESTING, A BD SECONDARY SET WAS USED. THE BD SECONDARY SET WAS CONNECTED TO A BAG FILLED WITH A BLUE DYE/WATER MIXTURE, AND THEN CONNECTED TO THE PRIMARY SET. THE SETS WERE SET UP IN A SECONDARY INFUSION CONFIGURATION WITH THE FLUID LEVEL OF THE SECONDARY BAG AT LEAST 9.5 INCHES HIGHER THAN THE PRIMARY BAG FLUID LEVEL, AND ALL OF THE CLAMPS CLOSED. THE SECONDARY SET WAS PRIMED WITH THE SECONDARY ROLLER CLAMP FULLY OPENED. FLUID FLOW WAS CONTROLLED USING THE PRIMARY ROLLER CLAMP. FLUID WAS FOUND TO BE FLOWING NORMALLY AND NO BACK FLOW WAS OBSERVED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A ROOT CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE FAILURE WAS UNABLE TO BE REPLICATED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ TUBING SET HAD A CHECK VALVE MALFUNCTION AND BACKFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN NOTED SECONDARY BACKFILLING INTO THE PRIMARY BAG."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ TUBING SET HAD A CHECK VALVE MALFUNCTION AND BACKFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN NOTED SECONDARY BACKFILLING INTO THE PRIMARY BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577228 UNSPECIFIED BD TUBING SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR