10FR 43 IRIS FEEDING TUBE ENF
Received Jun 21, 2021 · Event occurred Jun 14, 2021
Report 1282497-2021-10300 · MDR key 12032207
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A PHOTOGRAPH OF THE DEVICE WAS PROVIDED, AND A CRACK IS SEEN ON THE Y-PORT. THE ROOT CAUSE COULD NOT BE DETERMINED BASED SOLELY ON A PHOTOGRAPHIC EVALUATION. THE MANUFACTURING PROCESS OF THE Y-PORT ASSEMBLY, TESTS AND INSPECTIONS WERE REVIEWED. THEY PERFORMED LEAK TEST FOLLOWING ALL PRODUCT SPECIFICATIONS. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO THE CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THE ANALYSIS PERFORMED BY THE TEAM CONCLUDED THAT THE MAIN ROOT CAUSE IS RELATED TO A WORKMANSHIP ISSUE FOR THE DETACHED CONNECTOR. CORRECTIVE ACTIONS WERE IMPLEMENTED BY INSTALLING A NEW SOLVENT DISPENSER FOR A BETTER HANDLING OF SOLVENT FOR THE ASSEMBLY PROCESS OF THE Y-PORT AND TO IMPROVE THE STRUCTURE OF THE Y-PORT DESIGN BY ELIMINATING THE ¿WING¿ DESIGN AND REPLACING IT WITH A ¿NO WING¿ DESIGN WHICH WILL INCREASE THE SURFACE AREA OF THE BOND STRENGTH FOR THE Y-PORT ASSEMBLY.
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE WAS PLACED ON (B)(6) 2021 AND BROKE ON (B)(6), 2021. A PHOTO WAS PROVIDED AND SHOWS THAT THE Y-PORT CRACKED AND A PORTION OF IT BROKE OFF. THERE WAS NO PATIENT INJURY.