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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735)
Event Date 06/16/2021
Event Type  Injury  
Event Description
It was reported that this patient on peritoneal dialysis (pd) was in the hospital.In additional follow-up, the patient's pd nurse reported the patient was experiencing symptom of abdominal pain.As a result, on (b)(6) 2021, the patient was seen in the outpatient pd and had a pd culture obtained.The nurse stated the pd culture grew the bacteria pseudomonas aeruginosa.The patient initiated on antibiotics therapy with one dose of cefazolin and ceftazidime intra peritoneal.Subsequently, on (b)(6) 2021, the patient was admitted to the hospital for peritonitis.Per the nurse, the patient received antibiotics (unknown medication) while hospitalized.The patient also had the pd catheter (not a fresenius product) removed and was transitioned to hemodialysis for renal replacement needs.On (b)(6) 2021, the patient was discharged from the hospital continuing outpatient hemodialysis.The nurse was not able to identify the exact cause of the event.However, the nurse confirmed the patient did not have any issues with fresenius device or product in relation to the peritonitis event.It was reported the peritonitis may have been related to a breach in aseptic technique as multiple family members assist the patient with pd treatments.(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 Key17532152
MDR Text Key321142290
Report NumberMW5139061
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 07/08/2021
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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