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 Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient just received an operation due to fibrin.During the first night on the cycler since the operation, the patient does not see fibrin and was using heparin in the solution bags but is still receiving the drain complication message.The patient did not receive this issue in drain 1 or 2 and is not able to drain better when changing positions.Upon follow up, the peritoneal dialysis registered nurse (porn) stated the patient's nephrologist and surgeon are aware the situation and evaluation of patient's pd catheter is in process at this time.Additional information was obtained through the pd nurse.The patient was found to have their omentum wrapped around the pd catheter causing the fibrin which resulted in the drain complications.There was no issue with any fresenius device or 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.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: 17530985
• MDR Text Key: 321088671
• Report Number: MW5137901
• 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: 06/07/2021

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