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

Model Number	125028
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The returned unit inflated and inflated without issue.The returned unit was inflated / deflated three times with and without the stylet wire contained in the tubing and the reported defect could not be detected on the unit returned for evaluation.A probable root could not be determined as the reported defect could not be detected on the unit returned for evaluation.All of our products undergo a four hour inflate / deflate test and it is at this stage of the process that any defected are identified and removed from the lot.The reported defect could not be detected on the unit returned for evaluation.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.
Event or Problem Description
According to the reporter, the device tracheal cuff had a deflation failure.There was 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: 9343676
• Report Number: 8020889-2019-00164
• Device Sequence Number: 11299006
• Product Code: BTS
• UDI-Device Identifier: 40884522008717
• UDI-Public: 40884522008717
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: 06/01/2022
• Device Model Number: 125028
• Device Catalogue Number: 125028
• Device Lot Number: 201706036X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1