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

Model Number	351U5979
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 11012774
• Report Number: 2936999-2020-00928
• Device Sequence Number: 869544
• Product Code: CAH
• UDI-Device Identifier: 20884522033319
• UDI-Public: 20884522033319
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 351U5979
• Device Catalogue Number: 351U5979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention