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

Model Number PERITONEAL CATHETER

Device Problem Product Quality Problem (1506)

Patient Problems Peritonitis (2252); No Code Available (3191)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: early start peritoneal dialysis: technique survival in long-term follow-up source: kidney blood press res: 2018;43:1699-1705, online publication: 23 november 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study which compared technique survival in a cohort of patients who started either early (defined as break-in period from 3 or 14 days after catheter insertion with no previous nephrologist follow up or patient/family training) or planned (defined as break-in period of more than 14 days after catheter placement regardless of previous nephrologist follow up) peritoneal dialysis (pd).A total of 154 patients initiated pd during the study period, 40 of which was early start pd.All patients were treated with lactate-buffered glucose dialysate.There were two different brands of machine in which the pd was performed either by the two.Comparing early vs.Planned-start groups, there were no differences regarding pd dropout for peritonitis.Less patients in early start group quit pd for peritoneal membrane failure in comparison to planned-start group.In multivariate cox-regression analysis, the only factors independently associated with technique failure were bmi and diabetes mellitus, whereas no differences regarding early vs.Planned-pd start were observed.Despite the adverse scenario for initiating dialysis, early start pd had similar outcomes in comparison to planned-start pd, after a relatively long follow-up period.This study brings one more piece of evidence to support pd as an alternative treatment for renal replacement therapy in the context of urgent/early start dialysis.

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10383528
• MDR Text Key: 202597374
• Report Number: 3009211636-2020-00186
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• 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