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

Device Problems Migration or Expulsion of Device (1395); No Flow (2991); Output Problem (3005)

Patient Problem Unspecified Infection (1930)

Event Date 05/28/2023

Event Type  Injury  

Event Description

The nurse stated that the patient missed treatment because she was having issues with draining (she tried both cycler and manual) and thus was not able to dialyze.Later after hospitalization it was found that the patient had a pd catheter migration that led to the drain complications and subsequent infection/ hospitalization.File #: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD)
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488044
• MDR Text Key: 320684406
• Report Number: MW5120768
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1