BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 18339227 · Received December 15, 2023

    Report

    Report Number
    3014704491-2023-00820
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 12, 2023
    Report Date
    March 20, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    UDI-DI
    00382903886388
    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. NO SAMPLE WAS RETURNED, NO DEFECTIVE PICTURES WERE RETURNED; 2. REVIEW BATCH RECORD INFORMATION, 1) THE COMPLAINT LOT#2259586 WAS PRODUCED IN THE PRN AUTOMATIC ASSEMBLY LINE, THE PRODUCTION DATE IS 2022-10, AND THE M860 PACKAGING MACHINE WAS PACKAGED IN 2022-10, AND THE BATCH OF PRODUCTS TOTALED (B)(4). 2) CHECK THE PROCESS INSPECTION AND SHIPMENT INSPECTION REPORT OF THIS BATCH OF PRODUCTS. THE TEST RESULTS MEET THE PRODUCT STANDARDS AND THERE IS NO ABNORMALITY. 3) CHECK THE PRODUCTION RECORDS AND MACHINE MAINTENANCE OF THIS BATCH OF PRODUCTS, AND THERE ARE NO ABNORMALITIES, DEVIATIONS OR REWORK ACTIVITIES. 3. PERFORMED THE FUNCTION TEST FOR THE RETAINED SAMPLE OF COMPLAINT LOT, THE TEST RESULT IS PASS , SEE THE ATTACHMENT2 -TEST REPORT OF RETAINED SAMPLE , ATTACHMENT1 -TEST VIDEO OF RETAINED SAMPLE. 4. ROOT CAUSE CANNOT BE CONFIRMED, THE PLANT CONTINUES PAY ATTENTION TO THIS DEFECT. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; (B)(6) PATIENT RETURNED TO THE ROOM FROM SURGERY, REPLACED THE TEE TO CONNECT THE SINGLE-USE HEPARIN SODIUM, DURING INFUSION THE HEPARIN SODIUM RUBBER TIP CONNECTION LEAKED, RESULTING IN A WASTE OF MEDICATION, NO OTHER HARM, GIVEN TO REPLACE THE NEW SINGLE-USE HEPARIN CAP AFTER THE INFUSION IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041577 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD (SUZHOU) 2259586 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown