MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Type  Injury  

Event Description

This is a spontaneous report by a consumer with supplemental information provided by a nurse in the usa of exit site tunnel infection and peritonitis in a patient coincident with dianeal therapies for peritoneal dialysis (pd).On an unspecified date, pd therapy was discontinued and the patient was switched to hemodialysis (hd).On an unspecified date in 2012, the patient had a pd catheter placed.On an unreported date in (b)(6) 2012, the patient began therapy with dianeal solutions via cycler administered ip for pd.At the end of (b)(6) 2012 (specific date unknown), the patient's pd catheter was removed, pd therapy was discontinued again, and the patient was placed on hd.During a call with baxter technical service (bts), the following was reported.On an unreported date, the patient had an exit site tunnel infection, which resulted in peritonitis.The nurse reported that the patient did not have help in taking care of the pd catheter, which resulted in this infection.On an unreported date in (b)(6) 2012, the patient experienced peritonitis and was hospitalized on (b)(6) 2012.On an unreported date, a peritoneal effluent culture and gram stain were performed.The culture was positive for staphylococcus aureus and the stain was gram positive.The patient was treated with vancomycin.The patient was still hospitalized.The patient recovered from this peritonitis event on an unknown date in (b)(6) 2012.The nurse did not have any information pertaining to the brand name, lot number, or manufacturer of the catheter.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: 17525628
• MDR Text Key: 321089317
• Report Number: MW5132569
• 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: 01/25/2013

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