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

Model Number DIALYSIS UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Title: "greater omentum folding in the open surgical placement of peritoneal dialysis catheters: a randomized controlled study and systemic review." source: nephrol dial transplant, volume 29, 2014 (687¿697).Date of publication: 30 september 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed between march 2008 to december 2012, to analyze the outcomes of omentum management in pd catheter implantation,a total of 67 pd subjects were enrolled in the study and randomly assigned to receive either regular open insertion (roi group, n = 33) or open insertion with omentum folding (oiof group, n = 34).The primary outcome was defined as pd catheter tip migration with dysfunction.In both groups, all patients received a straight two-cuff pd catheter.In the course of this study, catheter-associated infections occurred with similar frequency in the roi (n = 8; 24.2%) and oiof group (n = 9; 26.5%; p = 0.980), including peritonitis (6.1 versus 8.8%; p = 0.724), tunnel infections (0 versus 2.9%, p = 0.621) and exit-site infections (18.2 versus 14.7%, p =0.623).

• Brand Name: DIALYSIS UNKNOWN
• 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: 8537793
• MDR Text Key: 142688353
• Report Number: 3009211636-2019-00096
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/22/2019

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: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 04/22/2019
• 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