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

Model Number	125032
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2017
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 communication that the unit had a broken cuff.Customer indicated that there was no patient involved in this event.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6822937
• Report Number: 8020889-2017-05123
• Device Sequence Number: 1522602
• Product Code: BTS
• UDI-Device Identifier: 30884522008727
• UDI-Public: 30884522008727
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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 Model Number: 125032
• Device Catalogue Number: 125032
• Device Lot Number: 201610246X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1