MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888119369P
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to the dialysis treatment, the catheter cuff was exposed, and after the treatment, the catheter was exposed for another 6cm.The patient mentioned that her (b)(6) child had pulled on her catheter a day prior to her going for her dialysis treatment.It was stated that the catheter was removed by the staff, and upon removal, it was noticed that there were raised lesions on the outer surface of the dialysis catheter.It had been noted that the patient's skin seemed swollen along the track of the catheter, but no signs of infection were present.The patient's skin was being cleansed with 2% chg swabstick or betadine swabstick.A new catheter was placed last (b)(6) 2018, and dialysis was being done on a regular scheduled day with no further complications.
Additional Manufacturer Narrative
Evaluation summary: because 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.The physical sample involved in the reported incident was not returned for evaluation.Three photos were provided by the customer.Visual evaluations of these photos were performed; the pictures show a palindrome catheter rested on a table, in these photos were observed the section of them has bubbles or blistering in the sleeve.This defect was confirmed with the photo provided by the customer.Based on the available information could not be attributing to manufacturing process.The most probable root cause can be considered as that the customer used a different cleaning agent from recommended.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls 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.
Event or Problem Description
According to the reporter, prior to the dialysis treatment, the catheter cuff was exposed, and after the treatment, the catheter was exposed for another 6cm.The patient mentioned that her (b)(6) year-old child had pulled on her catheter a day prior to her going for her dialysis treatment.It was reported that the catheter suture wings were intact but the sutures were removed within the standard 6 week post central venous catheter (cvc) insertion date, and on (b)(6) 2018 it was documented that the cvc was snuggly situated right at the exit site.The catheter was removed by the staff, and upon removal, it was noticed that there were raised lesions on the outer surface of the dialysis catheter.It had been noted that the patient's skin seemed swollen along the track of the catheter, but no signs of infection were present.The patient's skin was being cleansed with 2% chg swabstick or betadine swabstick.Betadine was used routinely as cleaning agent.The site was dressed with gauze each dialysis treatment which was 3 times weekly, and a triple antibiotic ointment (neosporin) had been used consistently.The central venous catheter was inserted on (b)(6) 2017 in diagnostic imaging.The new catheter was placed on (b)(6) 2018, and dialysis was being done on a regular scheduled day with no further complications.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7479337
• Report Number: 3009211636-2018-00137
• Device Sequence Number: 1417794
• Product Code: MSD
• UDI-Device Identifier: 10884521157736
• UDI-Public: 10884521157736
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2019
• Device Model Number: 8888119369P
• Device Catalogue Number: 8888119369P
• Device Lot Number: 1702700126
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR