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	09/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during the pre-test the cuff would not deflate.The customer reported that there was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: one device returned for evaluation contained in a plastic bag along with its original opened unit pack.Visual examination shows that shape of the tubing has been altered using the stylet wire and the tracheal cuff is stretched over the tracheal cuff notches.The style wire was removed from the tubing and 5mls of air was removed from cuff body.The stylet wire was replaced in the tubing and the returned unit was inflated using the parameters set out in if001.The returned unit inflated however an attempt made to deflate the returned unit failed.The stylet wire was removed from the tubing and 3mls of air was removed from the tracheal cuff.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.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: 6914505
• Report Number: 8020889-2017-05147
• Device Sequence Number: 1239339
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 05/01/2021
• Device Model Number: 125037
• Device Catalogue Number: 125037
• Device Lot Number: 201605489X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1