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

Device Problems Microbial Contamination of Device (2303); Device Fell (4014); Failure to Clean Adequately (4048)

Patient Problems Fever (1858); Pain (1994); Peritonitis (2252)

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient went to the hospital and was there a couple of days because of peritonitis.Upon follow-up, the nurse reported that the patient was experiencing symptoms of abdominal pain and fever.As a result, the patient was hospitalized with peritonitis.The patient's pd culture (obtained on (b)(6)2021) grew the organisms escherichia coli (e.Coli) and streptococcus viridians.Per the nurse, the patient continued pd treatments and received antibiotic therapy with vancomycin and cefazolin intra-peritoneal (ip) while hospitalized.On (b)(6)2021, the patient was discharged home continuing antibiotic therapy and pd treatment with the same cycler.The patient is recovering, according to the nurse.The patient's nurse stated the patient did not have any fluid leaks or any issues with fresenius device or product in relation to the peritonitis event.The nurse stated the event may have been due to a breach in aseptic technique, and dropping the pd catheter (not a fresenius product) on the floor.Upon further follow up, the pdrn stated the patient was in the process of unscrewing the old catheter cap and ended up dropping the catheter and line to the cycler set.The porn stated the open end of the catheter was the most probable source of contamination.The porn could not confirm neither if the catheter itself dropped to the floor nor the manufacturer of the catheter cap.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: 17534032
• MDR Text Key: 321157008
• Report Number: MW5140935
• 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: 04/09/2021

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