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

Model Number	126039
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2019
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
According to the reporter, during inspection before use, air was injected into the cuff, but the cuff could not be deflated.It has not been bent for intubation.The stylet was removed, but it could not be deflated.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation.Visual examination of the returned unit shows no sign of any defects.The returned unit was inflated / deflated three times and no defect noted.The reported defect could not be detected on the sample.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: 8595311
• Report Number: 8020889-2019-00040
• Device Sequence Number: 11258147
• Product Code: BTS
• UDI-Device Identifier: 30884522028978
• UDI-Public: 30884522028978
• 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): 07/18/2019

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: 10/01/2020
• Device Model Number: 126039
• Device Catalogue Number: 126039
• Device Lot Number: 201510384X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1