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

Model Number	125037
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2018
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, the air from the device was not deflated completely during cuff test.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for.Visual examination of the returned unit shows the shape of the tube has been altered using the stylet wire and there is a small amount of air contained in the tracheal cuff.The stylet wire was removed, and air was removed from the tracheal cuff.The stylet wire was replaced, and the returned sample was inflated using the parameters set out.Both cuffs inflated without any issue noted.Both cuffs deflated, and no issues noted.The stylet wire was removed, and the returned sample was inflated using the parameters set out.Both cuffs inflated without issue and both cuffs were fully deflated and no issue noted.The sample was inflated / deflated three times and no issue noted.The reported defect could not be detected on the returned sample when testing the tubing with the stylet wire contained in the tubing or when it was removed.All of our broncho cath products undergo a four hour inflate / deflate test and it is at this stage of the process that any defects are removed from the lot.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: 7666677
• Report Number: 8020889-2018-00065
• Device Sequence Number: 19490335
• Product Code: BTS
• UDI-Device Identifier: 30884522008741
• UDI-Public: 30884522008741
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 02/01/2022
• Device Model Number: 125037
• Device Catalogue Number: 125037
• Device Lot Number: 201702369X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1