BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET BN310 W/O BP Y-CONN

    MDR report key: 8692939 · Received June 12, 2019

    Report

    Report Number
    2243072-2019-01162
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 8, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. VISUAL INSPECTION OF RECEIVED SAMPLE: SBDM CONDUCT VISUAL INSPECTION OF RECEIVED SAMPLE, CRACK CAN BE FOUND ON THE Y-PORT. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOT NO. 2901121, 2902181 AND 2903162 OF THE HOUSE SAMPLES, THERE WAS NO CRACK ON Y-PORT ON THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF EXPECTED LOT NUMBER OF COMPLAINT SAMPLE (LOT NO. 2901121, 2902181 AND 2903162), NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE WAS NO SIMILAR ISSUE FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATION, SBDM CONDUCTED VISUAL INSPECTION OF THE COMPLAINT SAMPLE AND FOUND CRACK ON THE Y-PORT IN THE RECEIVED SAMPLE. THE CRACK ON THE Y-PORT CAUSED FLUID LEAKAGE AND THE CRACK COULD OCCUR DUE TO BELOW TWO CAUSES. FIRST, THERE WAS ASSEMBLY PROCESS FOR RUBBER AND Y-PORT BODY IN THE PLANT OF Y-PORT SUPPLIER. IN THE PROCESS, THE Y-PORT WAS DAMAGED BY TEMPORARY MALFUNCTION OF THE ASSEMBLY MACHINE. SECONDLY, THE CRACK COULD OCCUR DURING DELIVERY, AND IT WAS NOT DETECTED IN THE INCOMING INSPECTION IN SBDM SITE. SUBSEQUENTLY, THE I.V SET ASSEMBLY LINE WORKER DID NOT FIND THE CRACK DURING I.V SET ASSEMBLY PROCESS. CORRECTIVE ACTIONS: 1. SBDM CONDUCT QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY LINE WORKERS AND Y-PORT INCOMING INSPECTOR. 2. SBDM WILL IMPLEMENT TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR IV SET MANUFACTURING PROCESS. 3. SBDM WILL INFORM THE CASE TO Y-PORT SUPPLIER TO REVIEW THE Y-PORT MANUFACTURING AND DELIVERY PROCESS. SBDM HAS IN HOUSE CAPA-19-051 IN PLACE TO MONITOR TREND. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A IV SET BN310 W/O BP Y-CONN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CRACKED Y-SITE. FLUID LEAKAGE FROM Y-SITE CRACKED PARTS OF IV SET" UPDATED INFO: 1.WAS THERE AN EXPOSURE TO BLOOD OR MEDICINES? YES, IT WAS. THERE WAS A MEDICINES EXPOSURE TO THE CRACK OF Y-SITE. 2.IF EXPOSURE TO BLOOD OR MEDICINE WHAT WAS THE ROUTE OF EXPOSURE? WHO WAS EXPOSED, THE HEALTHCARE PROVIDER OR THE PATIENT? ACCORDING TO THE END-USER, THERE WAS A MEDICINES EXPOSURE TO THE CRACK OF Y-SITE. MEDICINES EXPOSURE WAS ONLY FOR THE PROVIDER. 3.WAS ANY TREATMENT PROVIDED? THEY STOPPED PROVIDING THE MEDICINE AND IMMEDIATELY REPLACED IT WITH A NEW PRODUCT."

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A IV SET BN310 W/O BP Y-CONN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CRACKED Y-SITE. FLUID LEAKAGE FROM Y-SITE CRACKED PARTS OF IV SET" UPDATED INFO: WAS THERE AN EXPOSURE TO BLOOD OR MEDICINES? YES, IT WAS. THERE WAS A MEDICINES EXPOSURE TO THE CRACK OF Y-SITE. IF EXPOSURE TO BLOOD OR MEDICINE WHAT WAS THE ROUTE OF EXPOSURE? WHO WAS EXPOSED, THE HEALTHCARE PROVIDER OR THE PATIENT? ACCORDING TO THE END-USER, THERE WAS A MEDICINES EXPOSURE TO THE CRACK OF Y-SITE. MEDICINES EXPOSURE WAS ONLY FOR THE PROVIDER. WAS ANY TREATMENT PROVIDED? THEY STOPPED PROVIDING THE MEDICINE AND IMMEDIATELY REPLACED IT WITH A NEW PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484290 IV SET BN310 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other