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

Model Number	8888541023
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2019
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, the catheter had come out from the patient after the catheter fixation had been confirmed and the sutures have been removed.They had used the catheter for a long time and they have followed their normal protocol in this case.No explanation could be found by interviewing the involved physicians or nurses.The access and exit sites were used for the first time.Catheter was implanted two (2) months ago.Sutures have been removed five (5) days before the catheter came out (migration issue).There was no luer adapter issue and had no leaks.Cleaning agent was used.Catheter was not repaired.Safety cap was utilized.Insertion site was treated prior to product placement.There was no other visible damage.New catheter was implanted two (2) days after to resolve the issue.There was no patient injury.

• 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: 8617393
• Report Number: 3009211636-2019-00124
• Device Sequence Number: 11258079
• Product Code: MSD
• UDI-Device Identifier: 10884521135482
• UDI-Public: 10884521135482
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K111817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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 Model Number: 8888541023
• Device Catalogue Number: 8888541023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 84