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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; 1LYRTR 16FR10ML100%SILI UMSNAP

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MEDLINE INDUSTRIES, LP Medline Industries, Inc.; 1LYRTR 16FR10ML100%SILI UMSNAP Back to Search Results
Model Number URO175816
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2023
Event Type  malfunction  
Manufacturer Narrative
According to the customer on (b)(6), there was "no urine output" from the foley catheter.Due to this, the foley was removed and a new catheter was placed.There was no injury or additional medical intervention reported related to the event.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
Catheter not draining.Additional catheter placed.
 
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Brand Name
Medline Industries, Inc.
Type of Device
1LYRTR 16FR10ML100%SILI UMSNAP
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
kelly zampella
three lakes drive
northfield, IL 60093
MDR Report Key16910656
MDR Text Key314988442
Report Number1417592-2023-00211
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10193489987461
UDI-Public10193489987461
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberURO175816
Device Catalogue NumberURO175816
Device Lot Number592210901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2023
Initial Date Manufacturer Received 04/13/2023
Initial Date FDA Received05/11/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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