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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 Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Physical Entrapment (2327)
Event Type  Injury  
Event Description
A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) since (b)(6) 2020 was experiencing "very bad" drain pain when the patient's residual peritoneal volume was approaching 500 ml.Follow-up with the patient's peritoneal dialysis registered nurse (porn) confirmed the patient underwent their third unsuccessful pd catheter (not a fresenius product) revision surgery on (b)(6) 2020.Per the porn, due to the patient's obesity their pd catheter (not a fresenius product) is becoming entangled in her bowels while prone, which is partially causing her drain pain.Additionally, the patient suffers from several undisclosed gi disorders (including irritable bowel syndrome) which are negatively impacting their ability to perform ccpd therapy pain free.The patient was transitioned to outpatient hemodialysis (hd) on (b)(6) 2020 until a plan can be formulated.The porn stated the events were unrelated to a malfunction or deficiency of any fresenius device(s) and/or product(s).The porn reported the patient's drain pain is a byproduct of her anatomy, comorbidities, and most recently her pd catheter insertion site was found to be leaking post-surgery (sutured-resolved).(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 Key17534999
MDR Text Key321169339
Report NumberMW5141899
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 11/06/2020
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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