MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAP,MUCUS,8FR,DELEE,W/VALVE

Catalog Number	DYND44108
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported to the manufacturer via a medwatch filed by the end-user that an infant was choking on a delee mucus trap device.Per the reporter, an infant was in their room with their father and the father called out for assistance.Reportedly the nurse entered the room and noted that the infant was choking on the delee device.The nurse reported that the device was coiling in the back of the infant's throat.No additional details are available related to the customer reported issue.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.There was no medical intervention, follow up care or serious injury reported related to this event.The sample has not been returned to the manufacturer 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 to the manufacturer via a medwatch filed by the end-user that an infant was choking on a delee mucus trap device.

• Common Device Name: TRAP,MUCUS,8FR,DELEE,W/VALVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9612839
• Report Number: 1417592-2019-00237
• Device Sequence Number: 11432347
• Product Code: BYZ
• UDI-Device Identifier: 10080196997411
• UDI-Public: 10080196997411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: DYND44108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/21/2020
• 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: Required Intervention
• Patient Weight: 3