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	Extubate (2402)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
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 the cuff on the tracheostomy tube would not deflate.The tube was removed and replaced.The customer indicated there was no patient injury with this event.
Additional Manufacturer Narrative
One sample returned for evaluation with visual examination showed no damage.The returned unit re-inflated then deflated without any restriction noted.The returned unit was inflated / deflated three times without the stylet wire and no issue was noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the cuff on the tracheostomy tube would not deflate.The tube was removed and replaced.The customer indicated there was no patient injury with this event.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6862523
• Report Number: 8020889-2017-05135
• Device Sequence Number: 788129
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 201611417X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention