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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX TRACHEOSTOMY TUBE
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NULL PORTEX TRACHEOSTOMY TUBE Back to Search Results
Lot Number UNKNOWN
Device Problems Inflation Problem (1310); Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  Injury  
Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Problem source found to be manufacturing.Dhr review could not be completed as no lot number was provided.
 
Event Description
It was reported that following an emergency cardiac surgery for thoracic pain at another facility, the patient was transferred from another into the icu unit of (b)(6) with an portex endotracheal tube size 7.5mm.The icu team of (b)(6) noticed that the cuff was not functional it did not hold pressure.The witness cuff was also deflated.
 
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Brand Name
PORTEX TRACHEOSTOMY TUBE
Type of Device
PORTEX TRACHEOSTOMY TUBE
Manufacturer (Section G)
NULL
MDR Report Key13416789
MDR Text Key284820963
Report Number3012307300-2022-02286
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/29/2020
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
Patient Outcome(s) Life Threatening;
Patient Age69 YR
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