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

Model Number 331/5661

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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, the patient was given a tracheal intubation connected to a ventilator to assist breathing due to decreased blood oxygen.The patient experienced a rapid heartbeat.The nurse immediately reported to the doctor.During the treatment, the nurse heard that there was a sound of air leakage at endotracheal intubation interface.After inspection, it was found that the interface of the breathing circuit was broken.Replaced a breathing circuit immediately and the patient's condition has eased.The customer stated unit did not turn on.

• 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: 11163386
• MDR Text Key: 226567517
• Report Number: 2936999-2021-00039
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: 12/17/2020
• 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
• Patient Age: 75 YR