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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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NULL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Device Problems Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problems Salivary Hypersecretion (4486); Insufficient Information (4580)
Event Date 08/06/2023
Event Type  Injury  
Manufacturer Narrative
A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
 
Event Description
It was reported that the customer was unable to pass suction catheter in trach, as it was obstructed 1-inch in.The trach was exchanged by an rt with an identical portex size 7mm with no relief.The trach was swapped out with a trach from a different manufacturer by the doctor and the patient's issues resolved.After the trach was exchanged the patient was transferred to the icu for close monitoring.Recent trach (same tube that was placed).Night before having increased secretions and pseudomonas growth.
 
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Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section G)
NULL
MDR Report Key17685645
MDR Text Key322668693
Report Number3012307300-2023-08692
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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