MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; GREENLINE D F/O LED LARGE HANDLE

Model Number 5-0236-69

Device Problem Break (1069)

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

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as it cause delay in therapy, the patient had to be re-intubated.

Event Description

Breaking during intubations.Potentially delayed intubation.

Manufacturer Narrative

Reportable as it cause delay in therapy, the patient had to be re-intubated.Complaint history reviewed.There have been 3 similar complaints in the previous 12 months.Without pictures of failure or returned product, complaint cannot be investigated further.When investigating for (b)(4), it was determined that complaint was confirmed, and product had a defect rate of 1/4360.Supplier is changing resin blend of handle to improve strength.See ncmr-02423/cc-07170 for more information.Risk (rma-20002b): r5: plastic heel breaking - torsion shear or tensile forces - s=7, o=2, rpn=14.Rpn < 25 therefore risk is acceptable.

Event Description

Breaking during intubations.Potentially delayed intubation.

• Brand Name: SUNMED HOLDINGS LLC
• Type of Device: GREENLINE D F/O LED LARGE HANDLE
• 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: 15124509
• MDR Text Key: 304791524
• Report Number: 1314417-2022-00018
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5-0236-69
• Device Catalogue Number: 5-0236-69
• Device Lot Number: 221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2022
• 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