MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Unspecified Infection (1930); Tachycardia (2095); Peritonitis (2252)

Event Type  Injury  

Event Description

This report was received from global pharmacovigilance (gpv) and is a spontaneous report from a consumer and supplemental information provided by a nurse in the usa of weakened spot on the catheter that tore, peritonitis and heart rate increases in a patient coincident with dianeal therapies for peritoneal dialysis (pd).It was not reported if dianeal therapies were ongoing.During a call with baxter customer services, the following was reported.On an unknown date in (b)(6) 2012 the patient experienced tunnel infection around the pd catheter.The patient was hospitalized for the tunnel infection (dates unknown).Cultures were performed and results showed pseudomonos.Treatment included unspecified antibiotics (dose and frequency unknown).There was a small hole on the pd catheter and the bed sheets were wet.The patient was instructed to clamp the area between the hole and himself and go to the hospital.On (b)(6) 2012 the patient experienced peritonitis and was directly admitted to the hospital.Culture results were unknown.Treatment included unspecified antibiotics (dose and frequency unknown).While hospitalized, the patient's pd catheter was removed, dianeal therapy was stopped and hemo therapy was started.It was reported that pd therapy would be restarted once the infection was cleared.Recovery status was unknown.The patient was still hospitalized at the time of report.The cause of tunnel infection was unknown.The cause of peritonitis was due to a weakened and thinning pd catheter.The patient had the pd catheter since (b)(6) 2002.The doctor told the patient it was time to change it but the patient wanted to wait until after the holidays.The patient had not yet recovered from this peritonitis 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: 17526927
• MDR Text Key: 321066379
• Report Number: MW5133864
• 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: 03/04/2013

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