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

Model Number 331/5661

Device Problems Break (1069); Crack (1135); Material Rupture (1546); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, postoperatively, the unit's extension tube connection port was ruptured.It was also reported that air leaked from the suction tube and endotracheal tube could be carefully observed and was found that the breathing circuit chain interface was cracked and was replaced immediately.There was no patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: no product was returned for evaluation.Confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• 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: 7735069
• MDR Text Key: 115767994
• Report Number: 2936999-2018-00476
• 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,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 331/5661
• Device Catalogue Number: 331/5661
• Device Lot Number: 17C1787FAX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1