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

Model Number	159-005
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Additional 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 became separated in the patient causing the clinician to intervene.
Event or Problem Description
The lma was being removed from the airway and the lma mask portion that seals against the airway in the patient's throat partially separated from the tube getting lodged in the back of the patient's throat and had to be extracted with a forceps.The item was inserted into the patient's airway and remained in place during the surgical procedure as designed.Once procedure ended the and the lma was being removed from the airway the lma mask portion that seals against the airway in the patient's throat partially separated from the tube getting lodged in the back of the patient's throat and had to be extracted with a kelly forceps.
Additional 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 became separated in the patient causing the clinician to intervene.Complaint not confirmed due to lack of photo of the nc product or a returned product.Sent request for root cause investigation investigation, see attached results.Visually inspected inventory the product in a different size and found no non-conformances.Reviewed complaint history for the 24 months preceding the complaint reporting and there was (b)(4) complaint for this part; there is no trending issue.(b)(4).Sent resolution to the customer.
Event or Problem Description
The lma was being removed from the airway and the lma mask portion that seals against the airway in the patient's throat partially separated from the tube getting lodged in the back of the patient's throat and had to be extracted with a forceps.The item was inserted into the patient's airway and remained in place during the surgical procedure as designed.Once procedure ended the and the lma was being removed from the airway the lma mask portion that seals against the airway in the patient's throat partially separated from the tube getting lodged in the back of the patient's throat and had to be extracted with a kelly forceps.

• Brand Name: SUNMED LLC
• Common Device Name: MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 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: 16258218
• Report Number: 1314417-2023-00002
• Device Sequence Number: 12454228
• Product Code: CAE
• UDI-Device Identifier: 10612479224183
• UDI-Public: 10612479224183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 159-005
• Device Catalogue Number: 159-005
• Device Lot Number: 2009010739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown