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

Model Number CURNASTUB50

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Aspiration/Inhalation (1725)

Event Date 05/01/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 296459047
• Report Number: 1417592-2022-00114
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 80884389113362
• UDI-Public: 80884389113362
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CURNASTUB50
• Device Catalogue Number: CURNASTUB50
• Device Lot Number: 44935
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention