MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP FASTENER,NASAL TUBE,ADULT,TAN

Model Number	CURNASTUB50
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient had a nasal fastener in place and within hours of placement the tubes would not remain secure.The tube was mis-positioned multiple times due the device adhesive not securing the tube.The tube was noted to be slipping out of the adhesive and had to be advanced because it was no longer in the appropriate location in the stomach.The device was in place for less than 6 hours and aspiration occurred with the patient due to inappropriate location.The tube was repositioned after multiple applications of nasal fasteners.The patient had small bore tubing placed by the provider and additional x-rays were required.The actual sample is not available to be returned for evaluation.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.
Event or Problem Description
It was reported that a patient had a fastener and in place and within hours of placement the tubes would not remain secure resulting in patient aspiration.

• Brand Name: FASTENER,NASAL TUBE,ADULT,TAN
• Common Device Name: FASTENER,NASAL TUBE,ADULT,TAN
• 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: 15089826
• Report Number: 1417592-2022-00114
• Device Sequence Number: 5101784
• Product Code: KGX
• UDI-Device Identifier: 80884389113362
• UDI-Public: 80884389113362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/22/2022

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: CURNASTUB50
• Device Catalogue Number: CURNASTUB50
• Device Lot Number: 44935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 07/22/2022
• 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