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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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COVIDIEN SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Lot Number 18B0601JZX
Device Problems Break (1069); Crack (1135); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
Event Type  malfunction  
Event Description
Rn was turning patient and recognized that pt's inner tracheostomy tube had started to slide out and was about half way out.Rn pushed it back into place and called rt.Rt came to assess and determined the white outer aspect of tracheostomy tube (white flange connected at 1200 to trach plate had broken off-the white flange is where the clear colorless inner tracheostomy tube secures to the hard white outer tracheostomy tube) was cracked and needed to be exchanged at bedside.Critical care transport nurse held tracheostomy tube in place while rt & provider were notified and preparing to exchange tracheostomy tube.
 
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Brand Name
SHILEY
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key7868076
MDR Text Key119945618
Report Number7868076
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number18B0601JZX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/14/2018
Event Location Hospital
Date Report to Manufacturer09/12/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age19710 DA
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