BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC

    MDR report key: 18956709 · Received March 21, 2024

    Report

    Report Number
    3002601200-2024-00096
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 28, 2024
    Report Date
    April 9, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903837564
    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

    1.DHR/BHR REVIEW: (1)THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3234106, IS 18G AND PRODUCT CODE IS 383756, PRODUCED ON 2023/09, WITH A TOTAL OF (B)(4)PIECES IN THIS BATCH; (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 PROVIDED TWO PHOTOS AND ONE VIDEO, FROM WHICH IT CAN BE SEEN THAT LIQUID OVERFLOWED FROM THE SLIT OF THE SEPTUM; THE CUSTOMER RETURNED A SAMPLE, AS SHOWN IN ATTACHED PHOTOS 1 AND 2. OBSERVED THE SEPTUM UNDER MICROSCOPE AND NO ABNORMALITIES WERE FOUND, AS SHOWN IN ATTACHED PHOTOS 3 AND 4; TAKE THE RETURNED SAMPLE DO 45PSI SYSTEM LEAKAGE TEST, AND NO LIQUID LEAKAGE WAS FOUND, AS SHOWN IN THE ATTACHED VIDEO 5; CUT THE SAMPLE OPEN AND TAKE OUT THE SEPTUM. OBSERVE THE SEPTUM UNDER MICROSCOPE. IT IS FOUND THAT THE SEPTUM IS DAMAGED IN THE NON-CENTER POSITION, AS SHOWN IN THE ATTACHED PHOTOS 6-8. 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, THIS DEFECT COMPLAINT IS THE SECOND TIME, AND THE RELEVANT COMPLAINT NUMBER IS PR#9694637. 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 CONCLUSION: NO ABNORMALITIES WERE FOUND IN THE PROCESS AND RETAINED SAMPLE PRODUCTS. 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 DETERMINED, AND THE FACTORY WILL CONTINUE TO MONITOR AND MONITOR THE TREND OF THIS DEFECT COMPLAINT. 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 GN 18GAX1.16IN PRN-CAP Y NON-PVC LEAKEDTHE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:DURING USE, BLOOD LEAKS FROM THE ISOLATION PLUG.A GREEN CLAIM IS REQUIRED, A REPLY LETTER IS REQUIRED, A COMPLAINT ACCEPTANCE LETTER IS REQUIRED, PHOTOS ARE REQUIRED, AND SAMPLES CANNOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360559 BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234106 00382903837564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown