MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CONNECTOR, AIRWAY (EXTENSION)

Model Number 331/5661

Device Problem Gas/Air Leak (2946)

Patient Problem Unintended Extubation (4564)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, a patient was given a tracheal intubation tube connected to a ventilator to assist breathing due to decreased blood oxygen.A sound of air leakage at the tracheal intubation interface was heard.After inspection, it was found that the breathing circuit interface was broken.Replaced a breathing circuit tube immediately.Hospital stay was prolonged.

• Brand Name: DAR
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 11146539
• MDR Text Key: 227536861
• Report Number: 2936999-2021-00030
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• PMA/PMN Number: K942392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 331/5661
• Device Catalogue Number: 331/5661
• Device Lot Number: 18A1092FAX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1