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

Model Number 8888423624

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 09/23/2013

Event Type  malfunction  

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 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
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8541722
• MDR Text Key: 145370058
• Report Number: 3009211636-2019-00102
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521084537
• UDI-Public: 10884521084537
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8888423624
• Device Catalogue Number: 8888423624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR