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

Model Number 331/5661

Device Problems Connection Problem (2900); Gas/Air Leak (2946)

Patient Problem Tachycardia (2095)

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 and a ventilator to assist breathing at 9:25 on (b)(6) 2020 due to decreased blood oxygen.At 12:30, it was found that the patient¿s heartbeat was speeding up and at the same time heard the sound of air leakage at the joint interface of the tracheal intubation.After checking, it was found that the joint interface of the breathing circuit was broken.An immediate replacement of the tracheal intubation was performed.

• 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: 11163433
• MDR Text Key: 226606189
• Report Number: 2936999-2021-00040
• 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 Outcome(s): Required Intervention