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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

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UNKNOWN CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252); Alteration in Body Temperature (4568)
Event Date 06/22/2021
Event Type  Injury  
Event Description
It was reported that a peritoneal dialysis (pd) patient was hospitalized for surgery and peritonitis.Upon follow-up, the patient's pd nurse reported the patient was experiencing symptoms of abdominal pain, fever and chills and complete malfunction of the pd catheter (not a fresenius product).The patient was seen in the outpatient pd clinic.However, the nurse stated a pd culture could not be obtained as the pd catheter was not working at all.Subsequently, the patient was sent to the hospital and admitted (the same day).It was reported that a pd culture could not be performed in the hospital as well due to the malfunctioning pd catheter.As a result, there is no documentation that assures the patient had peritonitis, according to the nurse.The nurse stated the peritonitis is presumed only at this point.It was reported the patient is being treated with intravenous (iv) antibiotics (medication details are unknown) while hospitalized.Additionally, the nurse indicated the patient had surgery to remove the pd catheter.Per the nurse, the patient will not require any further renal replacement (dialysis) as the patient has significant residual renal function and had only been completing pd treatment once per week.The patient is reportedly recovering.No further information about the hospitalization is available as the patient remained hospitalized at the time follow-up was completed.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.Fresenius product).The nurse attributed the suspected peritonitis to the malfunctioning pd catheter.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.C-805375 (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17531505
MDR Text Key321133449
Report NumberMW5138419
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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