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

Model Number UNKNOWN PERITONEAL CATHETER

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Obstruction of Flow (2423)

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

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

Title obstruction of peritoneal dialysis catheter is associated with catheter type and independent of omentectomy: a comparative data analysis from a transplant surgical and a pediatric surgical department source journal of pediatric surgery.53 (2018) 640-643, 2017.Date of publication: 30 jun 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the attached literature article refers to the comparison of complications and outcomes after implantation of peritoneal dialysis catheters in transplant surgical and pediatric surgical departments.The article includes 122 pediatric study participants and the following complications were reported: peritonitis: 33, obstruction/dysfunction: 31, leakage: 18, dislocation: 16, wound infection: 6, revision of peritoneal dialysis catheter: 53.It was observed that the perforation at the catheter tips was larger and appeared to be rougher in catheters used in pediatric surgical than the catheters in transplant surgical.

• 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: 8010040
• MDR Text Key: 125180744
• Report Number: 3009211636-2018-00344
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/26/2018
• 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; Required Intervention
• Patient Age: 3 YR