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

Model Number	125037
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
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 device's cuff could not be inflated.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for analysis and the reported issue could not be confirmed.Visual examination shows that the shape of the tubing is altered using the stylet wire and there is air contained in the tracheal cuff body.The stylet wire was removed from the tubing and 5 mls of air was removed from the tracheal cuff body.It was replaced into the tubing and the returned unit was inflated using the parameters set out in if001.The returned unit was inflated/deflated three times without any difficulty and without issue noted.The most probable root cause was the end user did not keep the white plunger in the inflation valve fully depressed during the inflation test.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 device's cuff could not be inflated.It was also reported that they tried to inflate the cuff but was not possible.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
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: 7530289
• Report Number: 8020889-2018-00053
• Device Sequence Number: 11237320
• Product Code: BTS
• UDI-Device Identifier: 30884522008741
• UDI-Public: 30884522008741
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 125037
• Device Catalogue Number: 125037
• Device Lot Number: 201701540X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/08/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention