MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 06/14/2012

Event Type  Injury  

Event Description

This report was received from global pharmacovigilance (gpv) and is a spontaneous report by a consumer with supplemental information provided by a nurse in the usa of catheter got dislodged and peritonitis in a female patient (born in 1950) coincident with dianeal therapy for peritoneal dialysis (pd).Dianeal therapy was ongoing.During a call with baxter customer services, the following was reported.On an unreported date, the patient's catheter had gotten wrapped around the omentum, which caused catheter dislodge.On (b)(6) 2012, the patient was diagnosed with peritonitis manifested by stomach pains.Cause of peritonitis was catheter dislodge.On (b)(6) 2012, the patient was hospitalized for peritonitis.On an unreported date, a peritoneal effluent culture was performed with unknown culture result.On an unreported date, the patient had a hemo access inserted into neck and started on hemodialysis until peritonitis went away.On (b)(6) 2012, the patient was discharged from the hospital.The patient recovered from this peritonitis event.Patient injury reported: yes.Medical intervention required: yes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533818
• MDR Text Key: 321161056
• Report Number: MW5140721
• Device Sequence Number: 1
• Product Code: FJS
• 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: 11/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1