MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DELEE MUCUS TRAP; TRAP, STERILE SPECIMEN

Catalog Number DYND44108

Device Problem Failure to Advance (2524)

Patient Problem Choking (2464)

Event Date 12/10/2019

Event Type  Injury  

Event Description

S: baby choking on medline delee mucus tap item dynd44108 b: infant choking in room dad called out for assistance, nurse went in room and took infant to nursery to delee.Grabbed the delee and attempted to delee.A: delee mucus trap product number dybd44108 is soft hard to pass and it was coiling in back of baby¿s throat as it would not pass.Fda safety report id # (b)(4).

• Brand Name: DELEE MUCUS TRAP
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 9504500
• MDR Text Key: 172616006
• Report Number: MW5091792
• Device Sequence Number: 1
• Product Code: BYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND44108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3