MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; EXTREMITY

Model Number	DYNJ902595G
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility during a procedure the breathing bag 'blew off the arm' requiring ventilation and an additional device.Per the facility the anesthesiologist 'was putting the patient to sleep and as soon as they grabbed the breathing bag to oxygenate, the bag blew off of the arm'.The staff placed an oxygen mask on the patient when the patient began de-saturate.The staff 'grabbed an additional circuit and attached the breathing bag to the machine'.Per the staff once the breathing bag was attached the patient became stable.According to the staff the 'plastic couple that connects the bag to the breathing arm was split'.A visual inspection of the device was performed and confirmed the stated issue of the connector splitting.Per the investigation a definitive root cause could not be determined based on the pictures provided.No additional information is currently available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility that during a procedure the breathing bag 'blew off the arm' requiring ventilation and an additional device.

• Brand Name: Medline Industries, Inc.
• Common Device Name: EXTREMITY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14119178
• Report Number: 1423395-2022-00011
• Device Sequence Number: 2427644
• Product Code: OJH
• UDI-Device Identifier: 10193489370737
• UDI-Public: 10193489370737
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: DYNJ902595G
• Device Catalogue Number: DYNJ902595G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown