BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18753614 · Received February 21, 2024

    Report

    Report Number
    3002601200-2024-00048
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 9, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903837564
    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 BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3234106, IS 18G AND PRODUCT CODE IS 383756, PRODUCED ON 2023/09, WITH A TOTAL OF 19000 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, AND NO COMPLAINTS OF THE SAME DEFECTS HAVE BEEN FOUND; CAUSE ANALYSIS: (1) ACCORDING TO THE ANALYSIS OF THE SAMPLES RETURNED BY THE CUSTOMER, IT WAS FOUND THAT THE SEPTUM WAS DAMAGED AT THE NON-CENTER POSITION, CAUSING THE SLIT OF THE SEPTUM TO BECOME LARGER, CAUSING THE PRODUCT TO LEAK AFTER THE NEEDLE WAS WITHDRAWN (NO LEAKAGE WAS FOUND IN THE TEST OF THE SAMPLE RETURNED BY THE CUSTOMER, WHICH MAY BE DUE TO THE LONG TIME HAS NOT BEEN USED, AND THE SEPTUM SLIT IS CLOSED AGAIN AFTER RE-STERILIZATION); (2) THE PRODUCT IS 18G, AND THE NEEDLE ASSEMBLY IS ASSEMBLED AT THE PG0050 STATION OF THE SEMI-AUTOMATIC LINE. AFTER CHECKING THE EQUIPMENT MAINTENANCE RECORD (ATTACHMENT 2), IT WAS FOUND THAT THE GUIDE GRIPPER OF THE NEEDLE ASSEMBLY HAS BEEN BROKEN. IT IS SUSPECTED THAT THE GUIDE GRIPPER IS BROKEN,CAUSING THE NEEDLE CAN NOT INSERT THE CENTER OF THE SEPTUM CORRECTLY. CORRECTIVE ACTION: (1) REPAIR AND REPLACE THE NEEDLE GUIDE GRIPPER.MODIFY THE NEEDLE ASSEMBLY MACHINE PARAMETER INSPECTION RECORD DOCUMENT MFG-11030-A, ADD DAILY INSPECTIONS OF THE GUIDE GRIPPER; (2) TRAINNING THE OPERATOR TO INSPECT NEEDLE ASSEMBLY PRODUCTS. IF FOUND THE PRODUCTS WITH ECCENTRIC NEEDLE, NEED TO BE REMOVED, AND NOTIFY THE TECHNICIANS TO ADJUST THE EQUIPMENT IMMEDIATELY. THE TRAINING RECORD AS SHOWN IN ATTACHMENT 2. IN SUMMARY, THIS COMPLAINT IS DUE TO THE GUIDE GRIPPER OF THE NEEDLE ASSEMBLY WAS BROKEN, FAILURE TO INSERT THE CENTER OF THE SEPTUM WHEN ASSEMBLING THE NEEDLE, CAUSING THE SLIT OF THE SEPTUM TO BECOME LARGER AND LEAKAGE. THE FACTORY HAS TAKEN RELEVANT IMPROVEMENT MEASURES AND WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE TREND OF DEFECT COMPLAINTS. H3 OTHER TEXT : SEE NARRATIVE.

    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

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: OOZING OF FLUID AND BLOOD AT THE INTERFACE OF THE INDWELLING NEEDLE IS SUSPECTED TO BE A PROBLEM WITH THE PRODUCT'S TIGHTNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415964 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