MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; TRAY TTL VENT 100%SILI UM 16FR

Model Number	URO180816S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient had a (b)(6) catheter placed on second shift and during night shift the patient reported that the catheter fell out.The staff nurse noted that the catheter was not in place and the balloon of the catheter was deflated so another (b)(6) catheter was placed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unwilling to provide further incident details to the manufacturer.The customer stated that they did not save samples to return for evaluation.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.
Event or Problem Description
It was reported that the indwelling (b)(6) catheter balloon deflated while inserted in the patient.The catheter fell out of the patient and was replaced with a new catheter.

• Brand Name: Medline
• Common Device Name: TRAY TTL VENT 100%SILI UM 16FR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13118080
• Report Number: 1417592-2021-00232
• Device Sequence Number: 11838475
• Product Code: OHR
• UDI-Device Identifier: 10889942767038
• UDI-Public: 10889942767038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

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: URO180816S
• Device Catalogue Number: URO180816S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown