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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Type  Injury  

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) experienced two pd catheter (not fresenius products) events.The first event occurred on (b)(6) 2020 (initial encounter), and the second on (b)(6)2021 (subsequent encounter).Follow-up communication from the patient's pd registered nurse (porn) revealed the patient was not hospitalized for either event.The porn reported on (b)(6)2020 drainage was noted coming from the patient's pd catheter exit site.The porn stated it was "not an infection," and the patient was successfully treated with oral and topical antibiotics (drug, dose, duration, frequency not provided).Additionally, the (b)(6)2021 event date was reportedly an evaluation by a surgeon to inspect the patient's pd catheter for a "tunnel infection." it was reported all tests were negative.Based on the available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530851
• MDR Text Key: 321131113
• Report Number: MW5137767
• 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: 06/21/2021

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