MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 351U5979

Device Problem Filtration Problem (2941)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, after patient was emerging from anesthesia, etco2 was lost and o2 saturation dropped precipitously.It was unable to move gases through filter due to suspected clogging with secretions.

• Brand Name: DAR
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11012774
• MDR Text Key: 221568194
• Report Number: 2936999-2020-00928
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 20884522033319
• UDI-Public: 20884522033319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 351U5979
• Device Catalogue Number: 351U5979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/15/2020
• 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