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

Model Number UNKNOWN PERITONEAL CATHETER

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cellulitis (1768); Peritonitis (2252); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Title pancreas adenocarcinoma: ascites, clinical manifestations, and management implications source clin colorectal cancer, volume 15, 2016 (1-24) article number: 4 date of publication: 1 december 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between january 1, 2009 and december 31, 2014 on 180 patients with pac (pancreas adenocarcinoma), of these, 108 had been inserted with a tenckhoff catheter and it was stated that there was a higher incidence of infections (spontaneous bacterial peritonitis: sbp) showing up in 23 patients on the catheters compared to 4 who had a paracenteses only.Other reported complications were catheter migration (8), abdominal wall cellulitis at the catheter site (2), bowel perforation (3), acute renal failure (5) and ascites leakage (3).

• Brand Name: UNKNOWN PERITONEAL CATHETER
• 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: 8097192
• MDR Text Key: 128180874
• Report Number: 3009211636-2018-00364
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2018

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: UNKNOWN PERITONEAL CATHETER
• Device Catalogue Number: UNKNOWN PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/21/2018
• 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): Other