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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Peritonitis (2252)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was in the hospital and the catheter was removed due to an infection.Upon follow up, the patient's pd registered nurse reported this patient presented to the outpatient clinic with pd catheter (not a fresenius product) exit site erythema and pain.Pd catheter exit site cultures taken presented with a heavy growth of escherichia coli.Peritoneal effluent fluid cultures taken in the outpatient clinic presented no growth after a five-day incubation period and a white blood cell (wbc) count of 162/mm3.The patient was diagnosed with a tunnel infection caused by a break in handwashing protocol that led to a peritonitis infection.The patient was prescribed intraperitoneal (ip) vancomycin at 1500 mg (frequency and duration unknown) and ip ceftazidime at 2000 mg every day (duration unknown).The patient presented to the emergency department on (b)(6) 2021 following a worsening of infection symptoms.A repeat wbc count taken on (b)(6) 2021 presented with 75/mm3.The patient's pd catheter was removed on (b)(6) 2021 as all modalities of dialysis were discontinued for this patient from an initial order from the nephrologist on (b)(6) 2021.The patient was released to home (date unknown).It was stated the patient has regained kidney function and will not continue any modality of dialysis following this event.There was no report the patient's tunnel infection leading to peritonitis was related to a deficiency or malfunction of any fresenius product(s) or device(s).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: 17531358
• MDR Text Key: 321067022
• Report Number: MW5138273
• 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: 06/21/2021

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