MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERITONEAL; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8888423624
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title radiological insertion of tenckhoff catheters for peritoneal dialysis: a 1-year single-centre experience source clin kidney j, volume 7, 2014(23-26) date of publication: 23 september 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
According to the literature source of study performed over the 12-month period, after post-insertion of dialysis catheter(s) which led to complications such as; catheter migration(13.3%) but only one required surgical intervention.Minor pain issues were noted (20%) and bleeding around the exit site requiring suturing (6.7%).Majority of the patients experienced minor pain/discomfort.

• Brand Name: PERITONEAL
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8541722
• Report Number: 3009211636-2019-00102
• Device Sequence Number: 313529
• Product Code: FJS
• UDI-Device Identifier: 10884521084537
• UDI-Public: 10884521084537
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888423624
• Device Catalogue Number: 8888423624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR