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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)
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MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR) Back to Search Results
Model Number 125035
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, prior to use an a patient, the unit's cuff could not be deflated.The customer reported that there was no patient involvement.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SHILEY
Common Device Name
TUBE, BRONCHIAL (W/WO CONNECTOR)
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
MDR Report Key7292073
Report Number8020889-2018-00023
Device Sequence Number11035488
Product Code BTS
UDI-Device Identifier30884522008734
UDI-Public30884522008734
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K771219
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/01/2021
Device Model Number125035
Device Catalogue Number125035
Device Lot Number201611418X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Initial Date Received by Manufacturer 02/02/2018
Supplement Date Received by Manufacturer03/27/2018
Initial Report FDA Received Date02/23/2018
Supplement Report FDA Received Date04/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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