MAUDE Adverse Event Report: MALLINCKRODT DAR SRL SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	SSVO
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, upon fitting the device onto the patient's tracheostomy tube, it immediately gave out loud noise and they had to take it off.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one sample was received not in its original opened packaging.The product was used for treatment.A visual inspection was performed and it was observed that no abnormalities were found.It was also noted that the lot reported by does not match with our plant lot.The received product met specifications.The complaint mode was not confirmed.No mitigation/correction required since sample returned is not defective.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, a speaking valve was applied to the patient's tracheostomy tube when it was heard to produce a buzzing sound so the usage was discontinued.The customer reported that there is no patient injury and that re intubation was not required.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 7384025
• Report Number: 2936999-2018-00211
• Device Sequence Number: 1274234
• Product Code: BTO
• UDI-Device Identifier: 40884522007734
• UDI-Public: 40884522007734
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K945407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 07/01/2020
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 15G1076JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 08/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1