BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC

    MDR report key: 14940583 · Received July 6, 2022

    Report

    Report Number
    3006948883-2022-00141
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 7, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 08-JULY-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1152550. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, SAMPLES WERE RECEIVED FROM THE FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE SURFACE OF THE CATHETER WAS FREE OF ANY DAMAGE OR ABNORMALITIES ASSOCIATED WITH THE STRUCTURE OF THE TUBING, THE OBSERVED BURR WAS AN ENTITY THAT WAS SEPARATE FROM THE TUBING. THE ISSUE HAS BEEN CONFIRMED. CLOSER INSPECTION INDICATED THAT THE BURR IS MOST LIKELY EXTRANEOUS SILICONE LUBRICANT, WHICH IS APPLIED TO AID IN THE INSERTION OF THE CATHETER. BASED ON A REVIEW OF THE MANUFACTURING PROCESS, OUR ENGINEERS BELIEVE THAT THE ROOT CAUSE IS ASSOCIATED WITH ACCUMULATION OF SILICONE AT THE APPLICATION STATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC BURRS WERE FOUND ON THE HOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IN THE DEPARTMENT OF ENT, WHEN I OPENED THE PACKAGE, I FOUND BURRS ON THE HOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC BURRS WERE FOUND ON THE HOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IN THE DEPARTMENT OF ENT, WHEN I OPENED THE PACKAGE, I FOUND BURRS ON THE HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257517 PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC CATHETER, INTRAVASCULAR FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1152550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown