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

Model Number PERITONEAL CATHETER

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/14/2016

Event Type  malfunction  

Manufacturer Narrative

Title: efficacy and outcomes of continuous peritoneal dialysis versus daily intermittent hemodialysis in pediatric acute kidney injury source: pediatric nephrology volume 31, pages 1681¿1689, 2016.14 may 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from oct-2013 to oct-2015, to check the efficacy and safety of continuous peritoneal dialysis (cpd) and daily intermittent hemodialysis (dhd) was compared in 136 children aged 1 month to 16 years requiring renal replacement therapy (rrt) for aki (acute kidney injury).Mechanical complications occurred at similar frequency with both treatment modalities (cpd -8, 10 % vs dhd -7, 13 %).In cpd, catheter leakage and migration were the main mechanical complications, but there was no need to interrupt therapy.In dhd,1 patient experienced exit site bleeding.There was no reported patient outcome.

• 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 street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10335837
• MDR Text Key: 200793881
• Report Number: 3009211636-2020-00163
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/28/2020
• 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 Age: 8 YR