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

Device Problems Contamination /Decontamination Problem (2895); Positioning Problem (3009)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

A clinic response was received which noted that this patient on peritoneal dialysis (pd) had their pd catheter repaired.In additional follow-up, the patient's pd nurse confirmed that on (b)(6) 2021, the patient underwent pd catheter (not a fresenius product) repositioning because the pd catheter became wrapped in omentum.Additionally, the nurse reported the pd catheter had a large fibrin sheath inside of the lumen which was cleaned out.Per the nurse, the patient did not have any adverse events related to use of fresenius device, or product.It was reported the patient continues pd treatment on fresenius cycler without any ill effects.(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: 17535396
• MDR Text Key: 321150126
• Report Number: MW5142293
• 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: 03/29/2021

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
• Patient Sequence Number: 1