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

Device Problem Contamination (1120)

Patient Problems Erythema (1840); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported a peritoneal dialysis (pd) patient was hospitalized due to an infection.Upon follow up, the pdrn stated they are familiar with the patient who was hospitalized on (b)(6) 2023 following erythema, edema and pain at their pd catheter (not a fresenius product) exit site.The pdrn reported the patient's exudate from their infected exit site was cultured in the hospital on (b)(6) 2023 which presented no growth and an elevated white blood cell (wbc) count (exact count unknown).The pdrn stated the patient?s peritoneal effluent fluid was obtained for cultures in the hospital on (b)(6) 2023 which also presented no growth and a wbc count within normal limits.The pdrn affirmed the patient was ruled out for a peritonitis infection.The pdrn stated the patient received a diagnosis of a tunnel infection due to a break in asepsis during pd catheter (not a fresenius product) care.The pdrn explained the patient allows pets in the same room that they clean their pd catheter (not a fresenius product), and their exit site was contaminated by pet dander.The pdrn reported the patient was prescribed intraperitoneal vancomycin for 10 days (unknown dose and frequency) prophylactically and topical gentamycin (unknown dose, frequency and duration) for the exit site infection.The pdrn stated the patient underwent hemodialysis (hd) for renal replacement therapy on a hospital provided fresenius hd device (unknown model) through a preexisting arteriovenous access to allow their exit site to heal.The pdrn reported the patient had an uneventful hospital course and was discharged to home on (b)(6)2023.The pdrn confirmed the patient's exit site infection, the associated symptoms and hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.File #: (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: 17488086
• MDR Text Key: 320696332
• Report Number: MW5120809
• 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: 06/16/2023

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