MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 12/22/2011

Event Type  Injury  

Event Description

This is a report of peritonitis in a female patient during peritoneal dialysis (pd) therapy.On an unreported date, the patient had catheter contamination while adjusting her catheter.On (b)(6) 2011, the patient was hospitalized for the event.On an unreported date, a peritoneal effluent culture was performed and the result was positive for methicillin resistant staphylococcus aureus.Treatment was not reported.Four days later, the patient was discharged from the hospital.On (b)(6) 2013, product surveillance spoke with the peritoneal dialysis nurse (pdrn) who confirmed the event.The pdrn stated that she does not have the information about the catheter, including the manufacturer.This information is unknown.No further information was provided.Patient injury reported: yes cmplnt- (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529632
• MDR Text Key: 321132483
• Report Number: MW5136557
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2013

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1