MAUDE Adverse Event Report: BAXTER CATHETER, ANGIOPLASTY,PERITONEAL, LONG TERM INDWELLING; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Positioning Problem (3009)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient's nurse reported that the patient was not able to drain since (b)(6) 2017.The patient was given heparin, there was no fibrin seen, and the peritoneal fluid was clear.The patient was then sent to the emergency room due to still not draining on (b)(6) 2017.The patient had an ongoing issue with constipation, however, the current drain complications is related to malposition catheter which will require repositioning.The patient also experienced a seizure.The patient used baxter products when seizure occured.The pd catheter is not a fresenius product line.Additionally, there was no allegation any fresenius peritoneal dialysis products.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, ANGIOPLASTY,PERITONEAL, LONG TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17536358
• MDR Text Key: 321108095
• Report Number: MW5143246
• 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: 08/31/2017

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