MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; HANDLE,LARYNG,LED,FO,DISP,SML,2CM DIAM

Model Number	MDS0425615
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 when attempting to intubate the patient for a procedure the anesthesia provider inserted the laryngoscope blade into the patient's mouth and when they went to lift up on the handle to visualize the airway the handle broke apart.After this occurred the anesthesiologist obtained a new handle and was able to intubate the patient without issue.Per the facility there was no noted injury and only 'a slight delay obtaining a new handle to continue with the intubation'.Per the facility there was no noted impact or injury to the patient.The sample was returned and a root cause could not be determined at this time.No additional information is available at this time.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 on (b)(6) 2022 when attempting to intubate the patient for a procedure the anesthesia provider inserted the laryngoscope blade into the patient's mouth and when they went to lift up on the handle to visualize the airway the handle broke apart.

• Brand Name: Medline Industries, Inc.
• Common Device Name: HANDLE,LARYNG,LED,FO,DISP,SML,2CM DIAM
• 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: 15324525
• Report Number: 1417592-2022-00151
• Device Sequence Number: 5505256
• Product Code: CCW
• UDI-Device Identifier: 10889942563708
• UDI-Public: 10889942563708
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: MDS0425615
• Device Catalogue Number: MDS0425615
• Device Lot Number: 22BBK08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG