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

Model Number	125041
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during pretest, the cuff would not completely deflate.Customer indicated there was no patient involvement with this event.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue could not be confirmed.The sample was returned and visual examination showed that the shape returned unit had been altered using the stylet wire.The stylet wire was removed and inflation/deflation testing was successful.There was no fault found with the device.The probable root cause is that the cuff test was carried out when the shape of the tube was incorrectly altered with the stylet wire.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that, during pre-use testing, the pilot cuff does not deflate completely.There is allegedly a defective valve.There is no patient involvement.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6623376
• Report Number: 8020889-2017-05047
• Device Sequence Number: 16309119
• Product Code: BTS
• UDI-Device Identifier: 40884522008762
• UDI-Public: 40884522008762
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 03/01/2022
• Device Model Number: 125041
• Device Catalogue Number: 125041
• Device Lot Number: 201703104X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1