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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)
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MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 110875
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Extubate (2402)
Date of Event 07/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during use, there was a condensation on the pilot balloon and 1.4 cc was collected after a week of intubation.When they tried to suction after 5 days, 1 cc was able to be suction.They suctioned 3.2 ml of water in the cuff on july 12, 3 ml on august 19, and 0.5 ml on august 22.They replaced it with a custom-made tube.
 
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Brand Name
SHILEY
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
MDR Report Key9115591
Report Number8020889-2019-00132
Device Sequence Number2591974
Product Code BTR
UDI-Device Identifier40884521068224
UDI-Public40884521068224
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K082520
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number110875
Device Catalogue Number110875
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2019
Initial Report FDA Received Date09/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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