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

Model Number	86398
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2019
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, the unit did not inflate.There is no patient involved in this event.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.Visual examination of the returned sample shows no sign of any defect.The sample was inflated using the parameters set out and inflated without issue.The sample was leak tested under water and no leakage detected.The sample remained inflated for twenty-four hours and no issue noted.The sample was inflated/deflated three times and no issue noted.The reported defect could not be detected on the unit returned for evaluation.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.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, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8865397
• Report Number: 8020889-2019-00087
• Device Sequence Number: 2119493
• Product Code: BTR
• UDI-Device Identifier: 30884522002060
• UDI-Public: 30884522002060
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K873461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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 Model Number: 86398
• Device Catalogue Number: 86398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1