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

Model Number	125037
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2018
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, during testing, the inflated tracheal cuff did not deflate.The customer indicated that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation contained in its original opened unit pack.Visual examination shows that the shape of the tubing is slightly altered using the stylet wire.The stylet wire was removed from the tubing and air was removed from the tracheal cuff and from the bronchial.The stylet wire was replaced into the tubing.The returned unit was inflated and deflated without any issue.The stylet wire was removed from the tubing and re-inflated without the stylet wire.The returned unit inflated/deflated without any issue.The returned unit inflated/deflated with and without the stylet wire and no restriction was noted.The reported defect could not be detected on the unit returned for evaluation.The most probable root cause is the adaptor was not fully depressed during the deflation stage of the process.All of our 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.The reported defect could not be detected on the unit returned for evaluation.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: 7309423
• Report Number: 8020889-2018-00026
• Device Sequence Number: 16416702
• 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): 06/20/2018

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: 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: 05/29/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1