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

Catalog Number	DYND44108
Health Effect - Clinical Code	Choking (2464)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 9504500
• Report Number: MW5091792
• Device Sequence Number: 1934614
• Product Code: BYZ
• 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: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND44108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• 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