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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problem Entrapment of Device (1212)
Patient Problems Bacterial Infection (1735); Peritonitis (2252)
Event Date 02/12/2022
Event Type  Injury  
Event Description
A peritoneal dialysis (pd) nurse reported that on (b)(6) 2022 this patient on pd therapy had a peritonitis event.The patient's pd culture (obtained on (b)(6) 2022) grew the bacteria staphylococcus epidermis.It was reported the patient was receiving antibiotic therapy (unknown antibiotics) and is recovering from the peritonitis event.Additionally, the nurse states the patient was continuing pd therapy on baxter products as that is what the hospital utilizes.However, subsequently during the hospitalization it was discovered that he patient's pd catheter (not a fresenius product) is entangled in the patient's omentum.Per the nurse, the pd catheter (not a fresenius product) has stopped working.The patient remained in the hospital and no further information about the hospitalization was available.The patient's nurse stated there were no fluid leaks or issues with fresenius device or product in relation to the peritonitis event.The nurse attributed the peritonitis to patient breach in aseptic technique during the pd exchange.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PERITONEAL DIALYSIS CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17524473
MDR Text Key321133326
Report NumberMW5131419
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 02/24/2022
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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