MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	TTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2019
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, prior to use, when the package was opened, it was found that the fastener part had come apart.It was indicated that there was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation.Visual examination of the returned sample shows the velcro strip on the short section of the tth has become detached from the fabric.Further examination shows the velcro strip is not attached to the fabric in the manner in which it is manufactured.The velcro strip was removed and examination shows the stitching is still attached to the velcro strip.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 TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8488576
• Report Number: 8020889-2019-00029
• Device Sequence Number: 16626346
• Product Code: JOH
• UDI-Device Identifier: 10884522042994
• UDI-Public: 10884522042994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: TTH
• Device Catalogue Number: TTH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1