MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10ML100%SILTMPS SNP

Catalog Number	URO175816TS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the balloon did not "occlude flow of urine through the urethra despite being fully inflated".The customer reported the balloon was "deflated, catheter repositioned, balloon re-inflated", however the issue persisted requiring a new catheter to be inserted.The customer reported the "syringe/water" from the kit was utilized for balloon inflation.The customer reported there was no injury related to the reported issue.The customer reported there was no serious injury related to the reported event.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on 09/23/2024 the balloon did not "occlude flow of urine through the urethra despite being fully inflated".

• Common Device Name: 1LYRTR 16FR10ML100%SILTMPS SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20507854
• Report Number: 1417592-2024-00911
• Device Sequence Number: 7920125
• Product Code: PPB
• UDI-Device Identifier: 40193489988513
• UDI-Public: 40193489988513
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: URO175816TS
• Device Lot Number: 592220702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 61 KG