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

Model Number	125032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2018
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, prior to use on a patient, the bronchus blue cuff was found torn.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation.An attempt made to inflate the bronchial cuff and failed.Visual examination shows that there is a large tear in the main body of the bronchial cuff.Further examination of the returned unit using the microvu shows that the tear is jagged in appearance.The tear measured 1.5cm in length.This type of damage is indicative of over inflation of the bronchial cuff.The reported defect could be detected on the sample returned for evaluation.The single wall thickness was measured away from the damaged area and found to be within the blueprint specification.The most probable root cause is the end user over inflated the bronchial cuff.The product relates to the reported complaint event.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: MALLINCKRODT
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7523630
• Report Number: 8020889-2018-00052
• Device Sequence Number: 1438538
• Product Code: BTS
• UDI-Device Identifier: 30884522008727
• UDI-Public: 30884522008727
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 09/01/2022
• Device Model Number: 125032
• Device Catalogue Number: 125032
• Device Lot Number: 201709218X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1