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

Device Problems Microbial Contamination of Device (2303); Failure to Clean Adequately (4048)

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

Event Type  Injury  

Event Description

It was reported a patient ((b)(6)) with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) since (b)(6) 2019 (approximation) experienced abdominal pain on (b)(6) 2021.The patient reported utilizing 5 bags of discolored (yellow) de/flex 4.25% solution between (b)(6) 2021 and was diagnosed with a catheter (type unspecified during intake) infection.Follow-up with the patient's pd registered nurse (pdrn) confirmed the patient presented to the outpatient dialysis clinic on (b)(6) 2021 with complaints of abdominal pain.An abdominal exam performed by the nephrologist revealed the patient contracted a pd catheter (not a fresenius product) exit site infection, characterized by redness, swelling and tenderness.A peritoneal effluent fluid culture and exit site swab were collected and the patient was started on oral keflex 500 mg twice daily for 14 days, and given a single prophylactic dose of intraperitoneal (ip) vancomycin 1500 mg.On (b)(6) 2021, the peritoneal effluent fluid culture returned negative (as expected), and the exit site grew staphylococcus aureus.The patient was ordered to continue taking the antibiotic for the full 14 days.The porn attributed causality to a touch contamination event due to the patient's poor personal hygiene and unkempt living conditions.The patient has been repeatedly educated about the importance of wearing the proper personal protective equipment (ppe), hand/body hygiene, and environmental cleanliness.The patient continues to perform ccpd and has recovered from the events.The porn stated the events were unrelated to any fresenius device(s) and/or product(s) deficiency (yellow discoloration) and/or malfunction.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(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: 17523621
• MDR Text Key: 321093697
• Report Number: MW5130569
• 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: 04/19/2021

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