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

Model Number	125032
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
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, the unit had deflation failure.There was no patient harm and recannulation/reintubation was not performed.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.Visual examination of the returned sample shows no sign of any defect.The sample was inflated using the parameters set out in and inflated without any issue.The sample was deflated without issue.The sample was inflated / deflated three times and no restriction noted.The reported defect could not be detected on the returned sample.The most probable root cause of this complaint is the shape of the tubing was altered using the stylet wire.All of our products undergo a four hour inflate/deflate test prior to release and it is at this stage of the process that any defects are removed from the lot.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: 8123222
• Report Number: 8020889-2018-00131
• Device Sequence Number: 1653403
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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 Model Number: 125032
• Device Catalogue Number: 125032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1