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

Device Problems Component Missing (2306); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported a peritoneal dialysis (pd) patient contacted fresenius technical support with a non-operational question.The patient had just left the hospital and the pd catheter (not a fresenius product) port was missing.The patient was advised to contact the on-call pd nurse.Additional information was obtained through follow-up with the patient's pd nurse.The patient was at the hospital for an outpatient procedure to correct the pd catheter placement.The patient was not admitted to the hospital and returned home the same day.The procedure was unrelated to use of the liberty select cycler or other fresenius product.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no a/legation of a device ma/function or deficiency reported for this event.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(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: 17535742
• MDR Text Key: 321192267
• Report Number: MW5142636
• 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: 11/01/2021

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