BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 18505110 · Received January 12, 2024

    Report

    Report Number
    1710034-2023-01529
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 18, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED ONE UNSEALED Q-SYTE UNIT FROM LOT NUMBER #2220533 FOR THE INVESTIGATION OF THIS COMPLAINT. A GROSS VISUAL INSPECTION SHOWS THAT THE UNIT DOES NOT HAVE PHYSICAL DEFECT. HOWEVER, PER THE CUSTOMER¿S VERBATIM, THE UNIT LEAKED DURING USE THUS THE UNIT WAS FURTHER INVESTIGATED. THE SEPTUM WAS REMOVED FROM THE BODY OF DEVICE AND WAS INSPECTED FOR DAMAGE. A 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 ON THE COLUMN WALL. THE TYPE OF DEFECT OF TEAR COLUMN WALL MAY OCCUR DURING MANUFACTURING DUE TO MISALIGNMENT OR DAMAGED/BURRED PROBES. HOWEVER, 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, THE DEFECT CANNOT CONCLUSIVELY BE LINKED TO EITHER MANUFACTURING OR USE RELATED AS THE DEFECT WOULD HAVE THE SAME APPEARANCE. INVESTIGATION CONCLUSION(S): THE DEFECT OF LEAKAGE WAS CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): NOT DETERMINED A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD Q-SYTE CLOSED LUER ACCESS DEVICES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE USE OF THIS PRODUCT, LEAKAGE WAS FOUND AT THE CONNECTION POINT OF THE SEPARATOR FILM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002632 BD Q-SYTE CLOSED LUER ACCESS DEVICE PERIPHERAL IV CATHETER FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2220533 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown