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

Model Number	86552
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: two samples were returned for evaluation.Both units were removed from their packs and visually examined.This examination confirms that the main stem of the tubing was compressed at the 17cm depth marking.This compression was for a distance of 5mm.This type of damage was indicative of the user pressing on the main stem of the tubing.An attempt made to replicate the damage detected on the returned unit and similar damage was observed when the main stem of the tubing was physically pinched using the thumb and forefinger.The reported defect was detected on one of the two units returned.The device failed to meet specification as it was received or made available for evaluation.The cause of the observed condition was determined to be abnormal stress.The dhr review shows the product was released to specification.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.
Event or Problem Description
According to the reporter, the patient bites down the endo tracheal tube and would not return to shape.It was also indicated that this cause wire to be exposed.They remove the et tube and put in another to resolve the issue.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; IE 3810
• MDR Report Key: 9662876
• Report Number: 8020889-2020-00007
• Device Sequence Number: 11432517
• Product Code: BTR
• UDI-Device Identifier: 10884521211681
• UDI-Public: 10884521211681
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K790575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 10/01/2023
• Device Model Number: 86552
• Device Catalogue Number: 86552
• Device Lot Number: 201810486X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1