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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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NULL DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 32-05-004
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
It was reported that valve opener became melted after the product underwent autoclave sterilization at 135 degrees celsius for 5 minutes.No patient injury was reported.
 
Manufacturer Narrative
Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.A device history record (dhr) review was conducted by the supplier.Product was received at supplier site for investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section G)
NULL
MDR Report Key15476633
MDR Text Key306262585
Report Number3012307300-2022-20202
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K903730
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number32-05-004
Device Lot Number0000210785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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