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 Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
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, during use, the device's holder broke.There was patient involvement, but there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation in a sample bag without its original unit pack.Visual examination of the returned unit shows it is discolored and there are some symbols in black marker on the product which are not from our manufacturing facility.Further examination also shows there is an 8cm section of the main section of the product missing.Examination of the small section of the product shows the narrow part has been torn away from its main section.This type of damage is indicative of undue force to the product.Three samples of in-house stock were checked and all three samples were found to meet our acceptance criteria.The reported defect could be detected on the unit returned for evaluation.The most probable root cause of this defect is an undue force to the product.All of products are packed on the packing machine.Each unit is folded prior to being placed in the preformed pack.The defect detected on the returned unit would not have passed this stage of our process.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: 8689865
• Report Number: 8020889-2019-00063
• Device Sequence Number: 16901634
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 07/19/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1