MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 14FR10ML LATEX UM SNAP

Catalog Number	URO175214
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility "the prefilled saline syringe has resistance, making it unable to be depressed when connected to balloon port".Per the facility there was no harm to the patient and another syringe was able to be used successfully.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 facility "the prefilled saline syringe has resistance, making it unable to be depressed when connected to balloon port".

• Common Device Name: 1LYRTR 14FR10ML LATEX UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19060139
• Report Number: 1417592-2024-00467
• Device Sequence Number: 5859862
• Product Code: PPB
• UDI-Device Identifier: 10193489987386
• UDI-Public: 10193489987386
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/08/2024

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
• Device Catalogue Number: URO175214
• Device Lot Number: 24ABT736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/08/2024
• 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
• Patient Sex: Unknown