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

Device Problems Contamination (1120); Device Fell (4014)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had a cap fall off and the extension set touched the bathroom floor.The nurse was not sure how the cap fell off or if it was just loose and came off.The patient is being treated with antibiotics.Upon follow up, the pd nurse confirmed that the patient was not in the middle of treatment and the event occurred at a golf club in the bathroom.The patient tucks the extension set into the pants for mobility.The pd nurse stated the patient was treated with antibiotics due to contracting peritonitis.Upon additional follow up, the patient's pdrn reported this patient presented to the outpatient clinic with complaints of abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic presented with pseudomonas stutzeri and a white blood cell (wbc) count of approximately 1 000/mm3.The patient was diagnosed with peritonitis due to touch contamination of the distal end of the pd catheter (not a fresenius product).It was reported the patient's cap to the pd catheter fell off in a public bathroom and the patient replaced the cap without washing hands or the cap.The patient was not hospitalized for this event and was prescribed intraperitoneal ceftazidime at 1000 mg every day for four weeks and oral cefazolin at 250 mg every day for two weeks.It was confirmed the portal of entry for this infection did not occur during ccpd therapy on the liberty select cycler and the patient's peritonitis was not due to a deficiency or malfunction of any fresenius device(s) or product(s).The patient is recovering from this event and continues ccpd therapy on the same liberty select cycler at home.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: 17522916
• MDR Text Key: 321088751
• Report Number: MW5129864
• 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: 10/05/2020

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