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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that while in use on a patient, after 3 hours, the cuff would not deflate.The cuff was pre-tested prior to use.Recannulation of a replacement tube was not required.There was no patient harm.
Additional Manufacturer Narrative
The sample associated to this report was received and the customer reported issue could not be duplicated. a visual examination was performed and showed the connectors were attached to the sleeves.Further examination showed that the tubing was slightly altered using the stylet wire and the tracheal cuff was stretched over the tracheal cuff notches.A inflation/deflation test was performed, air was applied to the cuff and removed from the cuff, a total of three times with and without the stylet wire.The returned unit re-inflated without any issue.The returned unit was then deflated without any restriction noted.The reported issue could only be detected when the stylet wire was contained in the tubing.Information has been added to the database and trends will continue to be monitored.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: 6745998
• Report Number: 8020889-2017-05082
• Device Sequence Number: 821646
• Product Code: BTS
• UDI-Device Identifier: 30884522008734
• UDI-Public: 30884522008734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2017

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: 11/01/2021
• Device Model Number: 125035
• Device Catalogue Number: 125035
• Device Lot Number: 201611179X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/19/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1