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

Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During a call to fresenius technical support (ts) for a draining issue, the contact for a peritoneal dialysis (pd) patient reported that the patient was admitted to the hospital for a pd catheter (not a fresenius product) adjustment surgery.Additional information was obtained through follow-up with the patient's pd nurse.The pd nurse confirmed that the patient underwent a pd catheter revision surgery.The pd nurse stated that the patient's draining issues were not related to the liberty select cycler, but it was pd catheter related.The patient is continuing pd therapy utilizing the liberty select cycler.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius device, product or other issue warranting further investigation.(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: 17533787
• MDR Text Key: 321152301
• Report Number: MW5140690
• 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: 03/04/2021

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