MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; 1LYR TRY 16FR 10ML 100% SILI UM SNAP

Catalog Number	URO175816
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "removing the patient's catheter- withdrew all 10ml of saline, got a second syringe, and double-checked that i removed it all, then pulled it.Upon removal, there was still a small amount of saline and/or air left, causing discomfort to the patient and ultimately a small amount of bleeding from the urethra".There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
Saline/air left in balloon during removal.

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 16FR 10ML 100% SILI UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25333057
• Report Number: 1417592-2026-01906
• Device Sequence Number: 9629599
• Product Code: PPB
• UDI-Device Identifier: 10193489987461
• UDI-Public: 10193489987461
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: URO175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/29/2026
• 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