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 from india of a catheter leak and peritonitis in a patient coincident with dianeal pd2 2.5% ultrabag therapy for peritoneal dialysis (pd).Dianeal therapy was ongoing.On an unreported date, a peritoneal effluent culture was performed with unknown results.The cause of the peritonitis was the catheter leak.The patient was not hospitalized for the peritonitis.On an unreported date, the patient was treated with vancomycin and fortum.At the time of this report, the patient was recovering from the peritonitis.The outcome of the catheter leak was not reported.Per the consumer, the event of peritonitis was unrelated to dianeal therapy.An opinion of causality was not reported for the event of the catheter leak.No information was available as to the product name, manufacturer, product code, or lot number of the catheter involved in this event.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: 17532124
• MDR Text Key: 321069264
• Report Number: MW5139033
• 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: 02/18/2013

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