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

Model Number	SSVO
Medical Device Problem Codes	Use of Device Problem (1670); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
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 pilot valve had a dimensional issue as the sound was not coming out correctly, the voice was low.There was no patient harm.

• 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
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13585206
• Report Number: 2936999-2022-00134
• Device Sequence Number: 19966709
• Product Code: BTO
• UDI-Device Identifier: 40884522005372
• UDI-Public: 40884522005372
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: 01/23/2024
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 19A0629JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/23/2022
• Date Device Manufactured: 01/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female