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 returned unit is altered, and the tracheal cuff is stretched over the tracheal cuff notch.The stylet wire was removed from the tubing and air was removed from the tracheal cuff body.The stylet wire was replaced into the tubing and the returned unit inflated.The returned unit inflated without any issue however an attempt made to deflate the returned unit failed.The stylet wire was removed from the tubing and air was removed from the tracheal cuff body.The returned unit was re-inflated.The returned unit re-inflated without any issue.The returned unit was then deflated without any restriction noted.The returned unit was inflated / deflated three times without the stylet wire and no issue was noted.The reported defect could only be detected when the stylet wire is 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 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: 7309414
• Report Number: 8020889-2018-00027
• Device Sequence Number: 1250144
• 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: 201702293X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• 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