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

Model Number 8PERC

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient came to change metallic cannula number 6 by polyvinyl to start a new treatment - radiotherapy, when changing had bleeding and treatment did not progress.It is necessary to place the portex on returning from radiotherapy, bleeding back only being possible to place the metallic cannula 5 then, forwarded to head and neck section.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11306838
• MDR Text Key: 231133394
• Report Number: 8020889-2021-00008
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K884730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8PERC
• Device Catalogue Number: 8PERC
• Device Lot Number: 15D0564J2X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1