BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GA X 1.16IN PRN-CAP Y

    MDR report key: 19029272 · Received April 2, 2024

    Report

    Report Number
    3002601200-2024-00115
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    1.DHR/BHR REVIEW: (1)THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3132817, IS 18G AND PRODUCT CODE IS 383952, PRODUCED ON 2023/06, WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; (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 SAMPLES AND ONLY PROVIDED 1 PHOTOS OF DEFECTIVE SAMPLES. FROM THE PHOTO, IT APPEARS THAT THE LIQUID MAY LEAKED FROM THE EXTENSION TUBE. 3.TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1. 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,SINCE THE CUSTOMER DID NOT RETURN SAMPLES, THE DAMAGE STATUS OF THE EXTENSION TUBE CANNOT BE CONFIRMED,THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE CONFIRMED, AND THE FACTORY WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE TREND OF THE DEFECT COMPLAINT. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS GN 18GA X 1.16IN PRN-CAP Y LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PROCEDURE, SODIUM CHLORIDE WAS ADMINISTERED TO THE PATIENT AND AFTER THIS INDWELLING NEEDLE WAS PLACED, THE INFUSION CLIP WAS OPENED SODIUM CHLORIDE WAS EJECTED FROM THE INDWELLING NEEDLE LINE. (SEE FIGURE FOR DETAILS)

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783066 BD PEGASUS GN 18GA X 1.16IN PRN-CAP Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3132817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown