BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GA X 0.75IN QSYTE

    MDR report key: 18268731 · Received December 5, 2023

    Report

    Report Number
    2243072-2023-02137
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 10, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903837137
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW: (1) THE PACKAGING BATCH NUMBER OF THE COMPLAINED PRODUCT IS 2175585, IS 24G AND PRODUCT CODE IS 383713, ASSEMBLED IN THE SUZHOU PLANT, THEN PACKAGED AND STERILIZED IN THE TUAS PLANT IN SINGAPORE; THE RELATED ASSEMBLY BATCH NUMBER OF THE PRODUCT IS 2081903, WERE ASSEMBLED IN 2022/04, THE BATCH OF PRODUCTS TOTALING (B)(4) PIECES; (2)INSPECTION PROCESS AND DELIVERY TEST REPORT, TEST RESULTS MEET PRODUCT STANDARDS, NO ABNORMALITIES; (3)CHECK THE PRODUCTION RECORD OF THE BATCH OF PRODUCTS, NO CONFORMANCE, DEVIATION OR REWORK ACTIVITIES IN THE PROCESS OF THE BATCH OF PRODUCTS; 2.THE CUSTOMER DID NOT RETURN ANY SAMPLES AND ONLY PROVIDED A VIDEO OF THE DEFECTIVE SAMPLES.FROM THE VIDEO, IT CAN BE SEEN THAT THE CUSTOMER USED A SYRINGE TO INJECT LIQUID AND THE LIQUID OVERFLOWED FROM THE SIDE OF THE Q-SYTE CONNECTOR; 3.THE Q-SYTE CONNECTOR OF THIS PRODUCT WAS ASSEMBLED IN TUAS PLANT, THE RETAINED SAMPLE IN SUZHOU PLANT DO NOT HAVE Q-SYTE CONNECTORS, SO CAN NOT DO THE RELATED TEST; 4.THE HISTORY OF CUSTOMER COMPLAINTS FOR THE SAME BATCH OF PRODUCTS HAS BEEN REVIEWED, AND NO COMPLAINTS OF THE SAME DEFECTS HAVE BEEN FOUND. IN SUMMARY, NO ABNORMALITIES WERE FOUND DURING THE ASSEMBLY PROCESS. ACCORDING TO THE VIDEO PROVIDED BY THE CUSTOMER, IT IS SUSPECTED THAT THERE WAS QUALITY ISSUE WITH THE Q-SYTE CONNECTOR,THE Q-SYTE CONNECTOR OF THIS PRODUCT WAS ASSEMBLED IN TUAS PLANT. THE PLANT WILL CONTINUE TO MONITOR THE DEFECT. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS YEL 24GA X 0.75IN QSYTE LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; ON NOVEMBER 10, A NURSE FROM THE THORACIC SURGERY DEPARTMENT OF THE INPATIENT UNIT OF (B)(6) HOSPITAL DISTRICT FOUND A LEAK IN THE CENTER OF THE CONNECTOR (NOT THE AREA WHERE THE SYRINGE CONNECTS TO THE CONNECTOR) WHEN USING A REGULAR SYRINGE CONNECTED TO A QSYTE CONNECTOR FOR SALINE PRE-FLUSH, AND TOOK A VIDEO, WHICH HAS BEEN REPORTED TO THE EQUIPMENT SECTION. THE NURSE SUBSEQUENTLY REPLACED THE POSITIVE PRESSURE CONNECTOR FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049306 BD PEGASUS YEL 24GA X 0.75IN QSYTE INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2175585 00382903837137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown