BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GA X 1.16IN PRN NON-PVC

    MDR report key: 19138167 · Received April 18, 2024

    Report

    Report Number
    3002601200-2024-00142
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 21, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903837557
    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

    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 3132811, IS 18G AND PRODUCT CODE IS 383755, PRODUCED ON 2023 06, WITH A TOTAL OF (B)(4). 2 INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY 3 CHECK THE PRODUCTION RECORDS FOR THIS BATCH OF PRODUCTS THAT THERE ARE NO NONCONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES IN THE PROCESS OF THIS BATCH OF PRODUCTS 2.THE CUSTOMER DID NOT RETURN SAMPLES AND PROVIDED 3 PHOTOS OF DEFECTIVE SAMPLES. FROM THE PHOTOS, IT CAN BE SEEN THAT THE BLOOD OVERFLOWED FROM THE SLIT OF THE SEPTUM 3.TAKE THE BATCH OF RETAINED SAMPLES FOR 45PSI SYSTEM LEAK PRESSURE 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. CAUSE ANALYSIS: ACCORDING TO THE PHOTOS PROVIDED BY THE CUSTOMER, THE BLOOD OVERFLOWED FROM THE SLIT OF THE SEPTUM,AND SEEMS TO BE CONTINUOUSLY LEAKING, SUSPECTED THAT THE SEPTUM WAS DAMAGED BUT DUE TO THE CUSTOMER DID NOT RETURN SAMPLES,CAN NOT CONFIRM WHETHER IT WAS DAMAGE TO THE SEPTUM RAW MATERIALS OR DAMAGE CAUSED DURING THE PRODUCTION PROCESS. IN SUMMARY, DUE TO THE CUSTOMER DID NOT RETURN SAMPLES, CAN NOT CONFIRM THE SLIT STATUS OF THE SEPTUM, THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE CONFIRMED. THE FACTORY WILL CONTINUE TO MONITOR AND MONITOR THE TREND OF THE DEFECT COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS GN 18GA X 1.16IN PRN NON-PVC HAD LEAKAGE AT THE ADAPTER TUBING JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: "THE INDWELLING NEEDLE CONNECTOR ALWAYS LEAKS."

    Description of Event or Problem · 0

    THE INDWELLING NEEDLE CONNECTOR ALWAYS LEAKS. CUSTOMERS REPORTED THAT AFTER OPENING THE PACKAGE AND SUCCESSFULLY PUNCTURING A NEEDLE, THEY FOUND LEAKAGE FROM THE RUBBER STOPPER OF THE INDWELLING NEEDLE WITHOUT ANY EXTERNAL DAMAGE. THEY THEN REMOVED THE INDWELLING NEEDLE AND REPLACED IT WITH A NEW ONE FOR PUNCTURE TO COMPLETE SUBSEQUENT TREATMENT. WHEN CHECKING THE COMPLAINT SAMPLE, IT WAS FOUND THAT THERE WAS A GAP IN THE RUBBER STOPPER OF THE INDWELLING NEEDLE. RESIDUAL BLOOD, NO OBVIOUS DAMAGE CAUSED BY EXTERNAL REASONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593292 BD PEGASUS GN 18GA X 1.16IN PRN NON-PVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3132811 00382903837557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown