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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

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UNKNOWN PD CATHETER; CATHETER, PERITONEAL Back to Search Results
Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A peritoneal dialysis (pd) patient reported that the tubing from their catheter burst and leaked fluid.The patient reported that they patched up the tubing.The patient was advised to contact their peritoneal dialysis registered nurse for assistance.Upon follow up, the patient stated they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient reported that the fluid leaked on their mattress and it occurred from the catheter insert site that connects to their body.The patient stated that the fluid leak did not come in contact with the cycler.The patient stated that they tore the plastic part on the catheter and reattached it back to themselves and then continued treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The catheter insert site used by the patient is not available for return for physical evaluation by the manufacturer.(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
Manufacturer (Section D)
UNKNOWN
MDR Report Key17523245
MDR Text Key321368235
Report NumberMW5130193
Device Sequence Number1
Product Code GBW
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 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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