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

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

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

Event Date 06/07/2021

Event Type  Injury  

Event Description

On 7/jun/2021, fresenius became aware peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2021.No additional information provided at intake.Follow-up with the patient's pd registered nurse (porn) revealed the patient was hospitalized on (b)(6) 2021, however the porn was unaware of the admission diagnosis.Despite this, the porn reported the hospitalization was unrelated to pd therapy or any fresenius device(s) and/or product(s) malfunction and/or deficiency.The nephrologist reportedly told the porn, the patient's pd catheter (not a fresenius product) was surgically replaced (date not provided) due to mal positioning.The surgery was successful, and the patient has continued undergoing ccpd throughout the hospitalization.Additional information (e.G., hospital records, treatment records) requested, however, the porn declined.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531825
• MDR Text Key: 321142729
• Report Number: MW5138736
• 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: 07/20/2021

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