MAUDE Adverse Event Report: UNKNOWN QUINTON ADAPTOR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Device Problem Material Split, Cut or Torn (4008)

Patient Problem 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 peritonitis with culture positive for corynebacterium and catheter was split/ pinhole in the tubing in a female patient coincident with dianeal pd4 ambuflex therapy.On an unreported date, the patient began treatment with dianeal pd4 ambuflex therapy (doses, frequencies and lot numbers not reported) "intraperitoneally" (ip) for peritoneal dialysis (pd).Dianeal therapy was ongoing.During a call with baxter customer services, the following was reported.On an unreported date, the patient's catheter was split/pin hole in the tubing.On (b)(6) 2012, the patient experienced peritonitis.On (b)(6) 2012, patient was hospitalized for the event.Cause of peritonitis was catheter was split / pin hole in the tubing.On an unreported date a peritoneal effluent culture was performed and the result was positive for corynebacterium.Treatment was not reported.On (b)(6) 2012, the patient was discharged from 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: QUINTON ADAPTOR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531069
• MDR Text Key: 321092308
• Report Number: MW5137985
• Device Sequence Number: 1
• Product Code: MPB
• 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: 01/10/2013

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