BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 21919078 · Received April 28, 2025

    Report

    Report Number
    3006948883-2025-00108
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    February 13, 2025
    Report Date
    May 26, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FPA
    UDI-DI
    00382903886388
    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. THE CUSTOMER RETURNED NO DEFECTIVE SAMPLE AND PHOTOS, SO THE LEAKAGE AND OTHER STATUS OF THE PRODUCT COULD NOT BE IDENTIFIED. 2. PRODUCTION RECORD INSPECTION (LOT#4050662): 1) THIS BATCH OF PRODUCTS WAS ASSEMBLED ON THE PRN AUTOMATIC LINE IN APRIL 2024 AND PACKAGED ON THE (B)(4) PACKAGING LINE IN APRIL 2024, WITH A WORK ORDER QUANTITY OF (B)(4). 2) CHECK THE PROCESS TEST REPORT AND THE SHIPMENT TEST REPORT, AND THE TEST RESULTS ALL MEET THE PRODUCT STANDARDS. 3) CHECK THE PRODUCTION RECORDS, AND THERE ARE NO UNQUALIFIED, DEVIATION OR REWORK BEHAVIORS. 3. CHECK THE RETAINED SAMPLE OF THIS BATCH FOR TESTING AND NO LEAKAGE WAS FOUND. CONCLUSION: NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS AND THE RETAINED SAMPLE. NO SIMILAR COMPLAINTS ABOUT THIS BATCH OF PRODUCTS WERE RECEIVED FROM OTHER HOSPITALS. AS THE STATUS OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE CANNOT BE CONFIRMED. THE FACTORY WILL CONTINUE TO TRACK AND MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER LEAKED ON (B)(6) 2025, AT ABOUT 16:00, THE PATIENT RETURNED TO THE WARD AFTER SURGERY, THE NURSE FOUND THAT THERE WAS LIQUID LEAKAGE AT THE PATIENT'S INDWELLING NEEDLE WHEN HE WAS IN JIAYE, THE NURSE CAREFULLY EXAMINED THE PATIENT AND FOUND THAT IT WAS A LEAKAGE FROM THE HEPARIN CAP, THE NURSE IMMEDIATELY SUSPENDED THE INFUSION TREATMENT, REPLACED THE HEPARIN CAP AND ADJUSTED THE POSITION OF THE SCALPEL NEEDLE TO CONTINUE TO CARRY OUT THE INFUSION TREATMENT FOR THE PATIENT, WHICH DID NOT HAVE ANY OTHER IMPACT ON THE PATIENT, AND THEN REPORTED IT TO THE HOSPITAL'S PURCHASING DEPARTMENT AND REPORTED AN ADVERSE EVENT OF THE DEVICE. THE HOSPITAL'S PURCHASING DEPARTMENT AND REPORTED THE DEVICE ADVERSE EVENT AFTERWARD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757798 BD PRN ADAPTER STOPCOCK, I.V. SET FPA BD SUZHOU (MDS) 4050662 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown