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

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had an infection in their "tube".Upon follow up with the peritoneal dialysis registered nurse (pdrn) it was reported the patient was unable to begin continuous cyclic pd (ccpd), due to a severe pd catheter (not a fresenius product) infection (organism, antibiotic not provided) he contracted while performing continuous ambulatory pd (capd).The patient's pd catheter required surgical removal and the placement of a hemodialysis (hd) catheter (not a fresenius product).The pdrn stated the patient's mother and father perform all the patient's activities of daily living (adls) and renal replacement therapy (rrt).The nephrologist and family agreed the transition of modality to home hd would be more appropriate for the family and patient.The family is beginning hd training on (b)(6) 2020.The porn stated the events were unrelated to the utilization of a fresenius device.(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: 17529209
• MDR Text Key: 321135312
• Report Number: MW5136138
• 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: 11/20/2020

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
• Patient Age: 37 YR