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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144)
Event Type  malfunction  
Event Description
On (b)(6) 2018 peritoneal dialysis (pd) patient reported feeling sick and throwing up.Upon follow up, the peritoneal dialysis nurse (porn) stated that the patient presented to the outpatient dialysis center experiencing nausea, vomiting.The pdrn stated that the patient had blood tinged peritoneal effluent fluid and pain following a catheter readjustment.The patient underwent a peritoneal dialysis catheter revision on (b)(6) 2018, and the hematoma was a byproduct of the revision.On (b)(6) 2018, the patient was hospitalized for inadequate peritoneal dialysis drains, blood tinged peritoneal effluent fluid and pain (severity unknown) in the right lower abdominal wall following the catheter readjustment.A computerized topography (ct) scan revealed a hematoma in the deep tissue of the right lower anterior abdomen.Additionally the inadequate drains and blood tinged peritoneal effluent fluid were also attributed to the presence: of the hematoma.The patient has continued peritoneal dialysis (pd) treatment on the cycler and has been performing pd therapy without any issues.The catheter used by the patient not a fresenius device.The manufacturer of the catheter is unknown.Ni.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, PERITONEAL, LONG-TERM INDWELLING
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17529251
MDR Text Key321458332
Report NumberMW5136180
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 04/26/2018
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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