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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 Malposition of Device (2616)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/14/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services underwent an invasive procedure.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient underwent a nonemergent outpatient procedure (exact date not reported) for a pd catheter (not a fresenius product) revision due to their catheter flipping upward in the peritoneum.It was affirmed the patient did not experience a serious injury that could potentially cause or contribute to this event.Additionally, it was confirmed the patient's pd catheter complication, and the associated procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered and continues ccpd therapy on the same liberty select cycler following this event.C-812837 (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
CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17531537
MDR Text Key321136762
Report NumberMW5138451
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 07/26/2021
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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