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

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 07/04/2020

Event Type  Injury  

Event Description

A patient contact reported that a peritoneal dialysis (pd) patient was currently in the hospital.Upon follow up, the peritoneal dialysis registered nurse (pdrn) was unaware of hospitalization.The pdrn indicated that the patient had history of peritonitis and recently had an infection.The pdrn stated that the patient had lower abdominal pain and the patient's catheter was replaced.Upon further follow up, the pdrn reported that the patient was hospitalized on (b)(6)2020 for peritonitis.The pdrn stated that the patient presented to the emergency room with severe abdominal pain, a peritoneal effluent fluid culture and cell count (results not provided) was obtained.The pdrn stated that the patient was given a single dose of intraperitoneal antibiotics in the emergency room, and the decision was made to pull the patient's pd catheter (not a fresenius product).On (b)(6)2020, the patient's pd catheter was surgically removed, and a temporary hemodialysis (hd) catheter (not a fresenius product) was placed.The pdrn stated that patient began hd on (b)(6)2020 without issue.The pdrn stated that the patient's peritoneal effluent fluid cultures returned positive for staphylococcus aureus, and the pdrn attributed cousality to a breach in aseptic technique.The pdrn stated that the patient reportedly stuck their finger in their pd catheter because they ran out of caps.Per the pdrn, the events are unrelated to the utilization of any fresenius product(s), drug(s) or device(s).The pdrn stated that the patient remains hospitalized and is recovering from the events.On (b)(6)2020, the patient's pd catheter was replaced, as the patient wishes to return to pd therapy upon discharge.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535737
• MDR Text Key: 321150426
• Report Number: MW5142630
• 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: 08/12/2020

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