MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 16FR10ML 100%SILI SNAP

Catalog Number	URO175716
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2024 the foley was placed prior to a surgical procedure but, the "nurse's documentation" stated when attempting to inflate the balloon the "saline flush would not push through the valve".
Additional Manufacturer Narrative
According to the customer, on 03/08/2024 the foley was placed prior to a surgical procedure but, the "nurse's documentation" stated when attempting to inflate the balloon the "saline flush would not push through the valve".The customer reported despite the nurse's documentation they "feel strongly that he would have used the syringe of sterile water that came in the kit".The customer reported an additional catheter was inserted in response to the reported issue.The customer did not report any serious injury.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.

• Common Device Name: 1LYRTR 16FR10ML 100%SILI SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19209784
• Report Number: 1417592-2024-00552
• Device Sequence Number: 15462516
• Product Code: PPB
• UDI-Device Identifier: 40193489987424
• UDI-Public: 40193489987424
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/29/2024

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: URO175716
• Device Lot Number: 24ABK172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown