| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PALINDROME | CATHETER, PERITONEAL DIALYSIS, SINGLE USE | COVIDIEN MFG SOLUTIONS S.A. | FKO | UNK DY | UNK DY | UNKNOWN | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-30 | 0 |
Patient 1
SUBMIT DATE: 2017/MAY/30. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER.THE CUSTOMER STATES THE PATIENT RETURNED TO THE FACILITY FOR DIALYSIS IN THE EIGHTH WEEK AFTER INSERTION OF THE CATHETER AND THE NURSE FOUND THE CATHETER WAS FREELY MOVING IN AND OUT OF THE ENTRY SITE.
Patient 1
AN INVESTIGATION WAS PERFORMED. SINCE NO LOT NUMBER WAS IDENTIFIED, A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW OR PRODUCT/PROCESS CHANGE REVIEW FOR THE INVOLVED LOT NUMBER COULD NOT BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO EVALUATE IT AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION. NO PROBABLE CAUSE WAS FOUND SINCE A SAMPLE, PICTURE OR VIDEO WERE NOT RECEIVED FOR TESTING; THEREFORE THE REPORTED ISSUE IS NOT CONFIRMED. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING ARE PERFORMED IN THE PLANT) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. THE LINE WAS DISCARDED BY THE PATIENT/RENAL NURSES SINCE IT IS A SINGLE USE ITEM. NO PHOTOS AVAILABLE. THE CUFF WAS COMPLETELY OUT WITH NO SIGNS OF FIBROSIS TO THE PATIENT'S TISSUE AFTER 6 WEEKS SUTURED. NO TRACT INFECTIONS AND SUTURES REMOVED AT 6 WEEKS. FEMALE, (B)(6) YRS, RIGHT JUGULAR LINE - 23CMS, LINE SLIPPED OUT IN THE 8TH WEEK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
THE CUSTOMER STATES THE PATIENT RETURNED TO THE FACILITY FOR DIALYSIS IN THE EIGHTH WEEK AFTER INSERTION OF THE CATHETER AND THE NURSE FOUND THE CATHETER WAS FREELY MOVING IN AND OUT OF THE ENTRY SITE.