MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Fluid/Blood Leak (1250)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

This report was received from global pharmacovigilance (gpv) and is a spontaneous report by a consumer with supplemental information by a nurse of peritonitis in a female patient coincident with dianeal therapy.The patient experienced peritonitis on (b)(6) 2013 and was hospitalized on the same day.The nurse stated the cause of the peritonitis was the catheter leaking.On an unknown date, the pd effluent was analyzed.It was unknown if the pd effluent sample was from before starting antibiotics.A culture was performed but the results were unknown.The patient was treated with vancomycin while in the hospital.The nurse stated the patient was hospitalized on (b)(6) 2013 for a leaking catheter and came out with peritonitis.The patient recovered from this event and was discharged on (b)(6) 2013.The pd therapy was ongoing while in the hospital.Patient injury reported: yes.Medical intervention required: yes, (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525087
• MDR Text Key: 321139108
• Report Number: MW5132028
• Device Sequence Number: 1
• Product Code: GBW
• 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: 11/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1