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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

On 05oct2012, during a call with baxter customer services, the nurse reported the following information.On an unreported date, the patient began treatment with dianeal pd2 ultrabag therapy (dose, frequency, and lot number not reported) intraperitoneally (ip) for peritoneal dialysis (pd).Dianeal therapy was ongoing.On (b)(6)2012, the patient was diagnosed with peritonitis.Cause of peritonitis was a tear in the pd catheter.The patient was not hospitalized for the event.Treatment was not reported.On an unreported date, a peritoneal effluent culture was performed which showed no growth.The patient was recovering from the event.Past medical history included end stage renal disease, hypertension, uncomfortable and cramping during therapy.The peritonitis was not related to dianeal therapy.Patient injury reported: yes.Medical intervention required: unknown.(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: 17535528
• MDR Text Key: 321152944
• Report Number: MW5142424
• 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: 10/17/2012

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