MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; ALL METAL F/O DISP MILLER SZ 2

Model Number 5-5336-02

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Laryngoscope blade broke off the handle during intubation.

Manufacturer Narrative

Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Manufacturer Narrative

Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Complaint confirmed with customer's photos.Reviewed the complaint history for the part and for the product family and there was no trending issue.Performed a risk analysis which indicated the severity rating of the complaint is 7/10.Determined root cause to be user error of not fully seating the blade in the handle.Sent resolution to the customer.

Event Description

Laryngoscope blade broke off the handle during intubation.

• Brand Name: SUNMED HOLDINGS LLC
• Type of Device: ALL METAL F/O DISP MILLER SZ 2
• 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: 15829902
• MDR Text Key: 307325673
• Report Number: 1314417-2022-00022
• Device Sequence Number: 1
• Product Code: CCW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5-5336-02
• Device Catalogue Number: 5-5336-02
• Device Lot Number: 215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/19/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 01/26/2023
• 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