MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; AIRQ3 STANDARD ILA WITH MANUAL CUFF INFLATION AND GA SIZE 4.0

Model Number 50405

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

The patient's small abrasion noted above uvula and above right tonsil.The improper placement or intubation process could have also been a cause for the patient's injury.

Event Description

Frank blood noted upon removal of airq lma size 4. frank blood noted upon removal of airway, with small abrasion noted above uvula and above right tonsil.

Manufacturer Narrative

The patient's small abrasion noted above uvula and above right tonsil.The improper placement or intubation process could have also been a cause for the patient's injury.The complaint of "frank blood noted upon removal of airq lma size 4" regarding part 50405 was not confirmed.The root cause cannot be determined but could possibly be a result of "device having sharp edges and corners at the patient end of the tracheal tube".An inventory analysis was performed and there were no nonconformances found.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding this reported issue.A resolution letter was sent to the customer.

Event Description

Frank blood noted upon removal of airq lma size 4. frank blood noted upon removal of airway, with small abrasion noted above uvula and above right tonsil.

• Brand Name: SUNMED LLC
• Type of Device: AIRQ3 STANDARD ILA WITH MANUAL CUFF INFLATION AND GA SIZE 4.0
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18637001
• MDR Text Key: 334493144
• Report Number: 1314417-2024-00011
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Device Model Number: 50405
• Device Catalogue Number: 50405
• Device Lot Number: 21D2905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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