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

Model Number UNKNOWN PERITONEAL DIALYSIS

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

Patient Problem Peritonitis (2252)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

Title: comparison with the conventional fan peeled catheterization effects of peritoneal dialysis catheter source china blood purification, volume 12, 2013(180-183).Article number: 4.Date of publication: april, 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from february 2009 to april 2012, during use with issues including catheter leak, catheter migration, exit site infection, peritonitis, catheter occlusion/dysfunction.The devices were used for treatment renal replacement therapy.One case using improved method had catheter leak issue, and the medical records were reviewed.The patient with obvious weight loss and a thin peritoneum.When the fan-shaped opener was applied into the peritoneal incision, the incision was enlarged, and the abdominal muscles were thin, leading to leakage.

• Brand Name: UNKNOWN PERITONEAL DIALYSIS
• 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: 8146873
• MDR Text Key: 129787067
• Report Number: 3009211636-2018-00386
• 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: 12/10/2018

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 DIALYSIS
• Device Catalogue Number: UNKNOWN PERITONEAL DIALYSIS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/10/2018
• 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): Required Intervention
• Patient Age: 40 YR