BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 15602061 · Received October 13, 2022

    Report

    Report Number
    9610847-2022-00398
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 11, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6:INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE Q-SYTE DEVICE IN AN OPENED PACKAGE FOR THE INVESTIGATION OF THIS INCIDENT. A GROSS VISUAL INSPECTION WAS PERFORMED ON THE RETURNED UNIT, AND NO DEFECT COULD BE FOUND ON THE UNIT. THE SEPTUM WAS REMOVED FROM THE BODY OF DEVICE AND WAS FURTHER INSPECTED FOR DAMAGE AND LEAK TEST WAS PERFORMED ON THE RETURNED UNIT USING A LUER LOCK SYRINGE.LEAKAGE WAS OBSERVED THROUGH THE VENT HOLES OF THE TOP BODY. THE COLUMN OF THE UNIT WAS THEN INSPECTED, AND A TEAR COULD BE SEEN ALONGSIDE THE COLUMN WALL THROUGH THE VENT HOLE. THE TYPE OF TEAR COLUMN WALL MAY OCCUR DURING MANUFACTURING DUE TO MISALIGNMENT OR DAMAGED/BURRED PROBES. FURTHER, THIS DEFECT MAY ALSO OCCUR IN THE CLINICIAN ENVIRONMENT DURING USE DUE TO EXCESSIVE ACTUATIONS OR EXTRANEOUS FORCE ON THE SEPTUM. AS THE DEVICE HAS BEEN OPENED AND HANDLED, IT CANNOT CONCLUSIVELY BE LINKED TO EITHER MANUFACTURING OR USE AS THE DEFECT WOULD HAVE THE SAME APPEARANCE. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE BI-DIRECTIONAL VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "CALL FROM THE PATIENT REPORTING HER WET KTC DRESSING. TOTAL DRESSING REPAIR, ASSESSMENT OF NOODLE INTEGRITY AND CORRECT HUB POSITIONING, REFLUX TEST AND INJECTION. LEAKAGE AT THE BI-DIRECTIONAL VALVE WAS NOTED. THE KTC WAS PLACED ON 08/09. CLINICAL CONSEQUENCES OBSERVED: NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE BI-DIRECTIONAL VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "CALL FROM THE PATIENT REPORTING HER WET KTC DRESSING. TOTAL DRESSING REPAIR, ASSESSMENT OF NOODLE INTEGRITY AND CORRECT HUB POSITIONING, REFLUX TEST AND INJECTION. LEAKAGE AT THE BI-DIRECTIONAL VALVE WAS NOTED. THE KTC WAS PLACED ON 08/09. CLINICAL CONSEQUENCES OBSERVED: NONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889221 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown