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

Device Problems Infusion or Flow Problem (2964); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

On (b)(6) 2022 during follow-up for file (b)(4), fresenius became aware this 48-year-old (b)(6) 1974 female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2022, for pain and drain complications (remains unknown if onset occurred during treatment).Follow-up with the patient's pd registered nurse (pdrn) revealed the patient presented to the emergency room on (b)(6) 2022 with complaints of abdominal pain.Radiological studies revealed the patient's pd catheter (not a fresenius product) migrated out of the proper position.The patient was taken to the operating room on (b)(6) 2022 and the pd catheter was successfully repositioned.The patient resumed ccpd therapy while admitted and no issues were noted.The patient was discharged on (b)(6) 2022 and has recovered from the events.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction despite the patient's request for a replacement.(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: 17488420
• MDR Text Key: 320686204
• Report Number: MW5121119
• 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: 12/20/2022

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
• Patient Age: 48 YR