BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOFLON PRO 26GA 0.6MM OD 19MM L INDIA

    MDR report key: 12515555 · Received September 22, 2021

    Report

    Report Number
    8041187-2021-00858
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-23. H6: INVESTIGATION SUMMARY. TWO PHOTOS AND ONE USED SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE FIRST RETURNED PHOTO SHOWS THE TOP WEB WITH BATCH 0110746. THE SECOND PHOTO SHOWS LEAKAGE BETWEEN THE CATHETER TIP AND THE TIP OF THE CANNULA HUB. THE USED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND DAMAGE WAS OBSERVED ON THE CATHETER TUBING INSIDE THE CANNULA HUB. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE MANUFACTURING PROCESS WAS REVIEWED. THE ASSEMBLY PROCESS INCLUDES FEEDING OF THE CATHETER TUBING SPOOL, 100% ONLINE OUTER DIAMETER INSPECTION OF TUBING, ANNEALING OF CATHETER BEFORE CUTTING TO REQUIRE TUBE LENGTH, AND THEN FLARING OF THE CUT TUBE ONTO THE METAL WEDGE. BASED ON THE SAMPLE RETURNED, THE PROBABLE ROOT CAUSE FOR THE LEAKAGE COULD BE DUE DAMAGE ON THE CATHETER TUBING. THE DAMAGE COULD HAVE BEEN INTRODUCED DURING THE FLARING PROCESS OF CUT TUBE INTO THE METAL WEDGE. THE INNER DIAMETER OF THE CATHETER TUBING COULD BE SMALLER AND THEREFORE, WHEN THE CUT TUBE WAS FLARED INTO THE METAL WEDGE, THE CUT TUBE INNER DIAMETER WAS STRETCHED AND BECAME DAMAGED. THERE WAS A QUALITY NOTIFICATION RAISED FOR THE CATHETER TUBING BATCH DUE TO TUBING INNER DIAMETER SMASHED OBSERVED. HOWEVER, A ROOT CAUSE WAS NOT CONFIRMED, AND NO CORRECTIVE ACTION WAS TAKEN DUE TO THE LOW OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEOFLON PRO 26GA 0.6MM OD 19MM L INDIA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEOFLON PRO 26G IS LEAKING FROM CANNULA HUB AFTER INSERTION WHILE IN USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEOFLON PRO 26GA 0.6MM OD 19MM L INDIA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEOFLON PRO 26G IS LEAKING FROM CANNULA HUB AFTER INSERTION WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412990 NEOFLON PRO 26GA 0.6MM OD 19MM L INDIA CATHETER FOZ 0110746

    Patients

    Seq Age Sex Outcome Treatment
    1