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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 125028
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.The returned unit inflated without issue.The returned unit deflated without any restriction noted.Probable root could not be determined as the reported defect could not be detected on the unit returned for evaluation.No new formal investigation is required, the event will be included in trending and monitoring.The product relates to the reported complaint event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the device tracheal cuff had a deflation failure.There was no patient involvement.
 
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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 Key9329639
Report Number8020889-2019-00161
Device Sequence Number11417063
Product Code BTS
UDI-Device Identifier40884522008717
UDI-Public40884522008717
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,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/15/2019
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 Date06/01/2022
Device Model Number125028
Device Catalogue Number125028
Device Lot Number201706036X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/02/2019
Initial Report FDA Received Date11/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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