MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125039
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/03/2018
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, during the cuff test, the air from the tracheal balloon would not deflate completely.The customer indicated that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for analysis and the reported issue was confirmed.The reported customer event is a known issue and root cause investigation efforts have been addressed in a corrective and preventative action.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7203738
• Report Number: 8020889-2018-00011
• Device Sequence Number: 1133556
• Product Code: BTS
• UDI-Device Identifier: 30884522008758
• UDI-Public: 30884522008758
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• 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 Date: 01/01/2022
• Device Model Number: 125039
• Device Catalogue Number: 125039
• Device Lot Number: 201701041X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1