| 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 | Y | 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 IN THE SEVENTH WEEK AFTER INSERTION THE PATIENT RETURNED TO THE FACILITY FOR DIALYSIS AND THE NURSE FOUND THE CATHETER WAS FREELY MOVING IN AND OUT OF THE ENTRY SITE.
Patient 1
THE PRODUCT CODE INVOLVED IN THIS COMPLAINT WAS UNKNOWN AND THE LOT NUMBER WAS ALSO UNKNOWN. SINCE NO LOT NUMBER WAS IDENTIFIED, A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW OR PRODUCT/PROCESS CHANGES REVIEW FOR THE INVOLVED LOT NUMBER COULD NOT BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. SAMPLE CONSISTED OF ONE PALINDROME CATHETER. THE SAMPLE CAME INSIDE A PLASTIC BAG AND SHOWED SIGNS OF USE. THE HUB AND PART OF THE CATHETER PRESENTED A YELLOW COLOR. THE CATHETER WAS CUT TO 17.5 CM BELOW THE HUB. VISUAL INSPECTION WAS PERFORMED AND THE CATHETER DID NOT PRESENT ANY ISSUES IN THE SUTURE WINGS. ADDITIONALLY, IN THE EVALUATION WAS OBSERVED THAT THE CUFF IS FIRMLY ADHERED TO THE CATHETER. AN ISHIKAWA DIAGRAM WAS USED TO DETERMINE THE POTENTIAL CAUSES FOR THIS EVENT. BASED ON THE SAMPLE EVALUATION, THERE IS EVIDENCE OF CORRECT GLUE APPLICATION, AND NO ISSUES WITH THE CATHETER WERE IDENTIFIED. HOWEVER, IT WAS NOTICED THAT TISSUE DIDN?T GROW AROUND THE CUFF. THE DWELL TIME IS UNKNOWN, HOWEVER WITH THE AVAILABLE INFORMATION IT IS POSSIBLE THAT THE TUNNEL WAS TO SHORT OR TOO BIG FOR THE CUFF AND THIS ALLOWED FOR POOR TISSUE IN-GROWTH ONTO THE CUFF. ADDITIONALLY IT IS POSSIBLE THAT THE SUTURE WING WAS NOT SECURED PROPERLY TO THE PATIENT. THE REPORTED CONDITION HAS NOT BEEN CONFIRMED. BASED ON THE SAMPLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH THE SOURCE OF THE REPORTED EVENT TO DETERMINE IF THIS FAILURE IS MANUFACTURING RELATED. BASED ON THIS INVESTIGATION, THE MOST POSSIBLE CAUSES ARE RELATED TO INCORRECT TUNNELING OR SUTURE WING NOT SECURED TO THE PATIENT. A TRIGGER WAS FOUND FOR THE PRODUCT FAMILY. THE OCCURRENCE PERCENTAGE FOR THIS FAILURE MODE WAS FOUND LOWER THAN THE EXPECTED LEVEL PER APPLICABLE RISK MANAGEMENT DOCUMENT. THE TRIGGER FOUND WAS ANALYZED ACCORDING TO PROCEDURE AND AS A CONCLUSION THIS COMPLAINT CONTINUES TO TRACK AND TREND BECAUSE NO LINK WAS FOUND TO THE MANUFACTURING PROCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. 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 IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
THE CUSTOMER STATES IN THE SEVENTH WEEK AFTER INSERTION THE PATIENT RETURNED TO THE FACILITY FOR DIALYSIS AND THE NURSE FOUND THE CATHETER WAS FREELY MOVING IN AND OUT OF THE ENTRY SITE.