MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNK - STRYKER 7 JACOB'S CHUCK

Device Problem Insufficient Information (3190)

Patient Problems Fungal Infection (2419); Insufficient Information (4580)

Event Type  malfunction  

Event Description

The catheter used by the patient is not a fresenius device.The manufacturer of the cather, 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: PERITONEAL DIALYSIS
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530464
• MDR Text Key: 321349586
• Report Number: MW5137383
• Device Sequence Number: 1
• Product Code: FKX
• 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: 04/08/2022

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
• Device Catalogue Number: UNK - STRYKER 7 JACOB'S CHUCK
• Patient Sequence Number: 1