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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. BLADE, TONGUE, 6", STERILE

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MEDLINE INDUSTRIES INC. BLADE, TONGUE, 6", STERILE Back to Search Results
Catalog Number MDS202075
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 01/13/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that the end user was under general anesthesia and the crna used a tongue depressor to assist with placement, when the distal tip of the tongue depressor broke off. The crna stated no excessive force was applied and the tongue depressor wood was cut across the grain, allowing the tongue depressor to "easily break" and pieces of the tongue depressor fell into the end users oropharynx. It was reported that "unsuccessful attempts" were made with forceps to retrieve the broken piece. The crna stated a piece went into the end users nasopharynx. A ent was brought in to retrieve the piece of the tongue depressor out of the right nare using video fluoroscopy. The end user was kept under anesthesia longer, due to the incident. The end user's physician ordered a swallow test, which showed a small esophageal tear, requiring the end user to remain npo and hospitalized for three days. It was reported the end user has fully recovered, since the incident. No additional information is available. The device was not returned to the manufacturer for evaluation. The customer reported issue was not confirmed. No additional information is available. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
The certified registered nurse anesthetist (crna) used a tongue depressor to expose the base of the tongue and the distal tip of the tongue depressor broke off and caused an esophageal tear.
 
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Type of DeviceBLADE, TONGUE, 6", STERILE
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
karen trutsch
three lakes drive
northfield, il 
MDR Report Key9808118
MDR Text Key186543348
Report Number1417592-2020-00025
Device Sequence Number1
Product Code FMA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMDS202075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
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 Unkown

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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