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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Malposition of Device (2616); Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 04/08/2021
Event Type  Injury  
Event Description
A patient on peritoneal dialysis (pd) called customer support for drain complication and report of pain/blood in the last drain of pd treatment with the fresenius cycler.The patient indicated this was her first treatment on the fresenius cycler since having her pd catheter replaced (on) and was not sure if she should have waited a few more days to do cycler assisted treatments.The patient was referred to talk to her nurse.In additional follow-up, the patient's pd nurse confirmed the patient underwent pd catheter (not a fresenius product) replacement on (b)(6) 2021 due to catheter malposition.The nurse stated the pain was associated with the pd catheter and resolved without medical intervention.It was reported the drain complications are associated with the pd catheter, but the patient has been able to complete her pd treatments.The nurse indicated the patient has not had any adverse effects from use of any fresenius device, or product.(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
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17536087
MDR Text Key321154267
Report NumberMW5142977
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 04/19/2021
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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