BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GAX0.75IN PRN-CAP Y NON-PVC

    MDR report key: 19698316 · Received July 8, 2024

    Report

    Report Number
    3002601200-2024-00293
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903837267
    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 3170878, IS 22G AND PRODUCT CODE IS 383726, PRODUCED ON 2023/07, WITH A TOTAL OF (B)(6) IN THIS BATCH; 2- CHECK THE PROCESS INSPECTION AND DELIVERY INSPECTION REPORT. THE TEST RESULTS ALL MEET THE PRODUCT STANDARDS AND THERE ARE NO ABNORMALITIES; 3- CHECK THE PRODUCTION RECORDS, THERE WERE NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2.TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1. 3.THE CUSTOMER RETURNED A SAMPLE, WHICH HAD BEEN USED, AS SHOWN IN ATTACHED PHOTOS 1-2. TEST THE SAMPLE WITH WATER INJECTION, AND FOUND THAT THERE WAS LEAKAGE BETWEEN THE PRN AND THE LUER CONNECTOR, AS SHOWN IN ATTACHED VIDEO 3. OBSERVE THE CONNECTION STATUS BETWEEN THE PRN AND THE LUER CONNECTOR, AND FOUND THAT THE PRN WAS ASSEMBLED WITH CROSS THREAD, THE SCREW THREAD OF THE PRN AND THE LUER CONNECTOR WERE NOT PROPERLY MATCHED, AS SHOWN IN ATTACHED PHOTO 4. REMOVE THE PRN AND REINSTALLED ON THE LUER CONNECTOR, THEN DO WATER INJECTION TEST AGAIN, AND NO LEAKAGE WAS FOUND, AS SHOWN IN ATTACHED VIDEO 5. 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 CONFIRMED THAT THE PRODUCT WAS LEAKAGE DUE TO THE PRN WAS ASSEMBLED WITH CROSS THREAD; 2- THE PRODUCT WAS ASSEMBLED ON THE AUTOMATIC LINE. THE INVESTIGATION FOUND THAT THE MOTOR POSITION OF THE PRN ASSEMBLED AT THE ZONE8 S39 STATION WAS POORLY ALIGNED, RESULTING IN THE CROSS THREAD OF THE PRN ASSEMBLY; CORRECTIVE MEASURES: THE FACTORY HAVE OPTIMIZED THE MOTOR POSITION ALIGNMENT OF THE ZONE8 S39 STATION IN JULY 2024. ATTACHED THE MAINTENANCE RECORD. CURRENTLY ARE PAYING ATTENTION TO AND MONITORING THIS DEFECT. IN SUMMARY, THE COMPLAINT WAS CAUSED BY THE CROSS THREAD OF THE PRN, WHICH CAUSED THE PRODUCT TO LEAKAGE. THE FACTORY HAVE OPTIMIZED THE MOTOR POSITION ALIGNMENT OF THE ZONE8 S39 STATION IN JULY 2024 AND IS CURRENTLY MONITORING AND TRACKING THE TREND OF THIS DEFECT.

    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 BL 22GAX0.75IN PRN-CAP Y NON-PVC LEAKED. THIS PRODUCT WAS IN USE AND APPEARED TO BE LEAKING BLOOD AT THE Y-JOINT; SAMPLE CAN BE RETURNED FOR 1 UNIT WITH PHOTOS PROVIDED; GREEN CLAIMS ARE REQUIRED, COMPLAINT RESPONSE LETTER IS REQUIRED, COMPLAINT ACCEPTANCE LETTER IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391656 BD PEGASUS BL 22GAX0.75IN PRN-CAP Y NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3170878 00382903837267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown