MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYR 16FR 10ML 100%SILI DB TRA

Catalog Number	DYND160716
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	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 06/05/2024 the "clinician described an inability to inflate the balloon after insertion".Per the facility the "clinician removed foley and inserted a new catheter".Per the facility the foley balloon was inflated with sterile water from inside the kit, however, the volume was unknown.Per the facility the patient is "okay".The sample was returned for evaluation, and a definitive root cause cannot be determined at this time.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.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 on 06/05/2024 the "clinician described an inability to inflate the balloon after insertion".

• Common Device Name: 1LYR 16FR 10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19721399
• Report Number: 1417592-2024-00727
• Device Sequence Number: 8147571
• Product Code: OHR
• UDI-Device Identifier: 40884389235134
• UDI-Public: 40884389235134
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/11/2024

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
• Device Catalogue Number: DYND160716
• Device Lot Number: 24DBD049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/11/2024
• 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: Unknown