MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient sent for x-rays which showed the pd catheter is "completely bent." the patient is having a tunnel catheter placed for temporary hemodialysis (hd) until the pd catheter is revised or replaced.Upon follow up, the nurse confirmed the patient is currently on back up hemodialysis while the pd catheter awaits intervention.The nurse confirmed that the patient did not have any adverse effects due to 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 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
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533651
• MDR Text Key: 321456784
• Report Number: MW5140555
• Device Sequence Number: 1
• Product Code: GBW
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1