MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; TTL1LYR 16FR10ML 100%SILI UM TRAY

Model Number	URO170816
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient was using a foley catheter for short term purposes and after approximately 2 days of the catheter being in place, the balloon on the foley catheter deflated.A new foley was reinserted without further issue reported.No additional information is available.Due to the reported incident and in an abundance of caution, this is a reportable incident.If additional information becomes available this report will be reopened and reevaluated.The sample has not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the balloon on the foley catheter deflated.A new foley was reinserted without further issue reported.
Additional Manufacturer Narrative
D9: sample available on (b)(6) 2022.The sample was returned for evaluation.The customer reported issue of the catheter balloon deflating was confirmed after visual inspection of the received sample.However, the definitive root cause could not be determined.No additional information is available.Due to the reported incident and 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.

• Brand Name: MEDLINE
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• 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: 13210582
• Report Number: 1417592-2022-00001
• Device Sequence Number: 16675336
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• 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,Followup
• Report Date (Section B): 03/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO170816
• Device Catalogue Number: URO170816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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: Required Intervention
• Patient Sex: Female