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

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized due to the catheter being clogged.The patient was currently at the hospital and was not able to provide additional information.Upon follow up, the patient's pd registered nurse (pdrn) reported this patient was hospitalized for a pd catheter (not a fresenius product) reposition.It was reported the patient's pd catheter had migrated into malposition which caused drain complications during ccpd therapy on the liberty select cycler at home.There was no report the patient experienced an infection, hernia or any adverse event that could cause or contribute to this event.The patient was able to undergo continuous ambulatory pd (capd) as capd was the preference for renal replacement therapy in this facility.The patient underwent a pd catheter reposition procedure on (b)(6) 2020 and was discharged the same day.It was confirmed the patient's pd catheter reposition and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and continues ccpd therapy on the same liberty select cycler at home post-discharge.Based on the required information, 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: CATHETER PD
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524834
• MDR Text Key: 321450820
• Report Number: MW5131777
• 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: 12/01/2020

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