POLYUR F T 6.5FRX36IN W ENFIT
Received Jun 23, 2021 · Event occurred May 17, 2021
Report 9612030-2021-02963 · MDR key 12051948
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3 EVALUATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO DISCREPANCY WAS FOUND ACCORDING TO THE REPORTED FAILURE. ONE DECONTAMINATED SAMPLE WITH THE REPORTED LOT NUMBER WAS RECEIVED. AFTER PERFORMING A VISUAL INSPECTION BASED ON PROCEDURE, IT CAN BE OBSERVED THAT THE TUBING WAS TRAPPED IN THE SEAL. THE PRODUCT BEING TRAPPED IN THE SEAL COULD CAUSE OCCLUSION OR SHEARING OF THE TUBE. THE REPORTED CONDITION WAS CONFIRMED. THERE IS CURRENTLY A FORMAL INVESTIGATION BEING CONDUCTED THROUGH A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WHICH WAS OPENED TO ADDRESS THIS TYPE OF FAILURE MODE THOUGH A MORE ROBUST INVESTIGATION.
Additional Manufacturer Narrative
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.
Description of Event or Problem
THE CUSTOMER REPORTED THE RN WAS GOING TO PLACE AN NG. WHEN THE RN OPENED THE PACKAGING OF THE NG TUBE, THE RN NOTICED THAT THE TUBE WAS SPLIT IN HALF. WHEN THE RN WAS INSPECTING THE TUBE, THE RN ALSO NOTICED THAT ON THE SIDE OF THE TUBE THERE WAS AN OPENING. THE RN REPACKAGED THE TUBE TO GIVE TO SUPERVISOR AND NOTIFIED THE SUPERVISOR OF THE EVENT. THAT SPECIFIC NG TUBE WAS NEVER INSERTED INTO THE PATIENT.