MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BLADE,LARYNG,F/O,MAC,METAL,DISP,#4

Catalog Number MDS0425504

Device Problem Break (1069)

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

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an emergency intubation, the laryngoscope was taken directly out of the intact/undamaged packaging and the blade opened to assure the light worked.The doctor was at the head of the bed to proceed with intubation.According to the facility, the blade was opened and inserted into the patient's mouth.The report stated that when the patient's airway was lifted to visualize the patient's vocal cords the blade fell apart.The facility reported that the blade and light wand shard were pulled out of the patient's mouth with the doctors fingers and placed in a bag.It was reported that a new blade was opened and the procedure continued without further incident.There was no impact to the patient or the procedure being performed.The patient was under anesthesia; however no additional anesthesia or medication was required.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There were no complications noted with the patient during or after the procedure.The facility reported that the patient is doing well, has been extubated and discharged from the facility.The actual device involved was returned for evaluation and the customer reported issue was confirmed however the root cause of the customer reported issue is unknown and could not be determined at this time.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that during an emergency intubation the laryngoscope blade and light wand fell apart in the patient's mouth.The pieces were manually removed without incident.

• Type of Device: BLADE,LARYNG,F/O,MAC,METAL,DISP,#4
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10601041
• MDR Text Key: 209357995
• Report Number: 1417592-2020-00097
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS0425504
• Device Lot Number: 19IBB539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85