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

Device Problems Fluid/Blood Leak (1250); Migration (4003)

Patient Problem Pain (1994)

Event Date 08/30/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was admitted to the hospital initially for experiencing pain and it was found that the catheter was coiled up.The patient underwent surgery to fix the issue on (b)(6) 2020.Upon follow up, the patient's pd nurse confirmed the pd catheter (not a fresenius product) was wrappped in the patient's colon and indicated the patient is currently on back up hemodialysis to let the catheter site heal.The nurse stated the patient did not have any adverse effects from use of any fresenius device, or product.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.The manufacturer of the catheter, and further product information, is unknown.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529444
• MDR Text Key: 321134481
• Report Number: MW5136370
• 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: 09/08/2020

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