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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TTL1LYR 16FR10ML 100%SILI DB TRA

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MEDLINE INDUSTRIES, LP Medline; TTL1LYR 16FR10ML 100%SILI DB TRA Back to Search Results
Model Number URO170716
Device Problem Material Integrity Problem (2978)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/13/2023
Event Type  Injury  
Manufacturer Narrative
According to the customer, the patient had a foley inserted on (b)(6) 2023 and "3 hours later" the balloon had "popped" causing "blood where the balloon would have been".The customer reported an additional catheter was placed and the balloon was found with a "longitudinal split".According to the customer the patient denies any "pulling/trauma".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
 
Event Description
According to the customer, the patient had a foley inserted on (b)(6) 2023 and "3 hours later" the balloon had "popped" causing "blood where the balloon would have been".
 
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Brand Name
Medline
Type of Device
TTL1LYR 16FR10ML 100%SILI DB TRA
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key17208637
MDR Text Key317942560
Report Number1417592-2023-00264
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10888277866911
UDI-Public10888277866911
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 06/27/2023
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 NumberURO170716
Device Catalogue NumberURO170716
Device Lot Number22LBS777
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2023
Initial Date FDA Received06/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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