MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 16FR10ML 100%SIL UM TR

Catalog Number	URO180816
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the foley catheter fell out of the patient partially deflated and caused unspecified trauma.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, or incident details to the manufacturer.The sample was received in used, unpackaged condition.No issues or abnormalities were found during testing, including at the vent, tubing, or bag.The reported issue of a deflating balloon was not confirmed through evaluation of the received sample.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 foley catheter fell out of the patient partially deflated and caused unspecified trauma.

• Common Device Name: TTLVENT 16FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8569045
• Report Number: 1417592-2019-00061
• Device Sequence Number: 2294114
• Product Code: OHR
• UDI-Device Identifier: 10889942687145
• UDI-Public: 10889942687145
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Catalogue Number: URO180816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other