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

Model Number	125035
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
Medtronic received a report that prior to use, during inspection, the cuff of an endobronchial tube could not be deflated completely.The customer reported that there was no patient involvement.The sample is expected to be returned.
Additional Manufacturer Narrative
Evaluation summary one sample was received for analysis and the reported issue could not be confirmed.A visual inspection was performed and it was observed all the components were assembled according to manufacturing process.A inflation/deflation test was performed, air was applied to the cuff and it was observed the cuff held the air and no deformations or anomalies were observed.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: 7054103
• Report Number: 8020889-2017-05191
• Device Sequence Number: 913113
• Product Code: BTS
• UDI-Device Identifier: 30884522008734
• UDI-Public: 30884522008734
• 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: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 03/31/2019
• Device Model Number: 125035
• Device Catalogue Number: 125035
• Device Lot Number: 201403291X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1