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

Model Number	125035
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2019
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, the unit had poor cuff and only one side bulging.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation in a sample bag along with its original open unit pack.Visual examination of the returned sample shows the shape of the tubing has been severely altered using the stylet wire.The stylet wire was removed and 3mls of air was removed from the tracheal cuff and 2mls from the bronchial cuff.The stylet wire was replaced and the returned sample was inflated using the parameters set out in if001 and inflated without issue.The bronchial cuff was fully deflated but the tracheal failed to fully deflate.The stylet wire was removed and 3mls was removed from the tracheal cuff.The returned sample was re-inflated using the parameters set out in if001 and both cuffs inflated without issue.Both cuffs were fully deflated and no issue noted.The sample was inflated/deflated three times and no issue noted.The reported defect could only be detected when deflating the tube with the stylet wire contained in the tubing.The most probable root cause is the tracheal cuff was stretched over the tracheal cuff notch during the deflation stage of the process.All of our bronchocath products under go 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: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 9189337
• Report Number: 8020889-2019-00149
• Device Sequence Number: 11384321
• Product Code: BTS
• UDI-Device Identifier: 30884522008734
• UDI-Public: 30884522008734
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 01/31/2020
• Device Model Number: 125035
• Device Catalogue Number: 125035
• Device Lot Number: 201501342X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1