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

Catalog Number DYND44108

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 12/10/2019

Event Type  Injury  

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 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.

• Type of Device: TRAP,MUCUS,8FR,DELEE,W/VALVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9612839
• MDR Text Key: 177943712
• Report Number: 1417592-2019-00237
• Device Sequence Number: 1
• Product Code: BYZ
• UDI-Device Identifier: 10080196997411
• UDI-Public: 10080196997411
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND44108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• 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
• Patient Weight: 3