MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 3, 4, 5,

Model Number 159-003, 004, 005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

Mckesson laryngeal mask is used in achieving and maintaining control of the airway during routine and emergency anesthetic procedures in fasted patients.During the procedure, the airway tube is causing soft tissue injury to patients.

Event Description

Causing soft tissue injuries to patients.

Event Description

Causing soft tissue injuries to patients.

Manufacturer Narrative

Mckesson laryngeal mask is used in achieving and maintaining control of the airway during routine and emergency anesthetic procedures in fasted patients.During the procedure, the airway tube is causing soft tissue injury to patients.Complaint confirmed with photo.Reviewed the complaint history for the 24 months preceding the complaint reporting date.There were only 2 complaints for the parts listed in the complaint in that timeframe.Discussed with clinical subject matter expert and determined the most likely root cause of clinician user error.Visually inspected similar part 159-001 inventory and no non-conformances were found.Performed risk analysis with (b)(6) and determined a severity rating of 7/10.Sent resolution to the customer.

• Brand Name: SUNMED LLC
• Type of Device: MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 3, 4, 5,
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand ledge MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand ledge MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand ledge, MI 49544 ; 6162598415
• MDR Report Key: 16258591
• MDR Text Key: 308307235
• Report Number: 1314417-2023-00003
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 159-003, 004, 005
• Device Catalogue Number: 159-003, 004, 005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other