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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 5,
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SUNMED HOLDINGS LLC SUNMED LLC; MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 5, Back to Search Results
Model Number 159-005
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem Respiratory Insufficiency (4462)
Event Date 12/30/2022
Event Type  malfunction  
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 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.
 
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 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.
 
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Brand Name
SUNMED LLC
Type of Device
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 Key16258218
MDR Text Key308634740
Report Number1314417-2023-00002
Device Sequence Number1
Product Code CAE
UDI-Device Identifier10612479224183
UDI-Public10612479224183
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
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 Received01/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number159-005
Device Catalogue Number159-005
Device Lot Number2009010739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2023
Date Manufacturer Received12/30/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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