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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UM TRAY
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MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UM TRAY Back to Search Results
Catalog Number URO170816
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported that a patient noted that she felt wet approximately fifteen (15) minutes after the urinary catheter was inserted.Reportedly, a staff member assessed the patient and noted that the pad underneath her was wet with urine.The staff member believed that urine was leaking from the urinary catheter's shaft.The urinary catheter was removed by the staff member and a new urinary catheter was inserted without further reported incident.No impact to the patient's stability or need for additional medical intervention and/or follow-up care was reported to the manufacturer.The urinary catheter involved in the reported incident was returned to the manufacturer for evaluation.Visual inspection of the urinary catheter revealed no defects or abnormalities.Functional inspection was performed by inflating the urinary catheter balloon with 10ml of water.The urinary catheter balloon inflated and deflated fully with no defects, abnormalities, or leakage noted.Water was then passed through the urinary catheter's eyelets and allowed to drain into the urine meter.All water was able to drain properly into the urine meter, with no defects to the urinary catheter noted or leakage identified.The reported product issue was not confirmed and a root cause for the reported incident could not be determined.Due to the need for medical intervention to remove and replace the urinary catheter, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported that the urinary catheter was leaking.The urinary catheter was removed and replaced.
 
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Common Device Name
TTL1LYR 16FR10ML 100%SILI UM TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
MDR Report Key8453785
Report Number1417592-2019-00038
Device Sequence Number2839741
Product Code OHR
UDI-Device Identifier10888277862623
UDI-Public10888277862623
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/26/2019
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? Yes
Operator of Device Health Professional
Device Catalogue NumberURO170816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/21/2019
Initial Report FDA Received Date03/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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