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

Model Number UNKNOWN PERITONEAL CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

Title surgical complications after peritoneal dialysis catheter implantation depend on children's weight source journal of pediatric surgery, 2016, (1317-1320) article number: 51 date of publication: 05 december 2015 this device has been reported as a general medtronic dialysis product, but no further information was provided.A variety of fda product codes are associated with this group of products, and the specific code cannot be identified with the information available.The most common fda product code for this type of device has been added to the product information within this report.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

This report was received via a journal of pediatric surgery, journal of pediatric surgery 51 (2016) 1317-1320.Surgical complications after peritoneal dialysis catheter implantation depend on children's weight.A retrospective review was performed on 61 patients who underwent peritoneal dialysis catheter implantation between 2009 and 2014.There were 17 out of 70 catheters needing a surgical revision within 6 months after implantation (24.3%).Peritonitis was the most common complication affecting 18.6% of peritoneal dialysis catheters followed by obstruction and dislocation, which occurred in 9 (12.9%) and 7 (10%) catheters, respectively.Leakage (n=5) only occurred in children with a weight of less than 10 kg.The total proportion of complications was higher in children with less than 10 kg of weight (p<(><<)>0.001).Conclusion: pd is safe in children with acute renal failure and older children with chronic renal failure; however, children with a weight of less than 10 kg are more likely to develop complications.

• 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: 7660653
• MDR Text Key: 113149810
• Report Number: 3009211636-2018-00223
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• 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: 07/03/2018

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: 06/04/2018
• Initial Date FDA Received: 07/03/2018
• 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