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

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

On (b)(6) 2023, during a follow up, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius she noted a pinhole in her pd catheter (not a fresenius product) and was hospitalized as a result.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) 2023 with a one quarter inch tear in her pd catheter (not a fresenius product) due to unknown etiology.It was explained it appeared as though the patient cut it; however, the patient denied cutting her catheter and the cause of the tear remains unknown.The patient was hospitalized on (b)(6) 2023 to undergo a surgical procedure to replace her pd catheter.The patient underwent one continuous ambulatory pd (capd) treatment during this admission as capd was the preference for renal replacement therapy in the admitting hospital.The patient had an uneventful surgical procedure and hospital course and she was discharged to home on (b)(6) 2023.It was confirmed the tear in this patient's pd catheter and the associated procedure and hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and resumed ccpd therapy on the same liberty select cycler at home post? discharge.File#: (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, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488491
• MDR Text Key: 320692119
• Report Number: MW5121190
• 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: 03/06/2023

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