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

Model Number	80XLTCP
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
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 unit's cuff would not inflate.The product and cuff failure led to respiratory compromise, inability to effectively oxygenate - haemodynamic instability followed and patient now on pressors.The patient had to be taken back to theatre to reinsert again a new device to minimize leaks the patient was not able to be turned or suctioned and huge risk of arway loss with endotracheal intubation to try or stabilize patient during the night.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation in a sample bag without its original unit pack.Visual examination of the returned sample shows it is heavily contaminated and there is also some black thread attached to the stationery flange.An attempt made to inflate the returned sample using the parameters set out in if001 failed.Further examination of the cuff using the microvu shows a clean cut to the cuff body measuring 2.1mm in length and 0.34mm at its widest point.This type of damage is indicative of coming in contact with a sharp utensil or object.The single wall thickness of the cuff was measured away from the damaged area and found to meet the blueprint specifications.The reported defect could be detected on the returned sample.All of our xlt cuffed proximal products undergo a four hour inflate/deflate test and it is at this stage of the process that any defects are removed from the lot.The damage detected o n the returned sample would not have passed this stage of our process.We would like to draw your attention to our instructions for use(ifu) where it states the following¿ to ease insertion and to guard against cuff perforation from sharp edges of cartilage, the cuff should be tapered back.This can be accomplished by first inflating the cuff.Then gently move the cuff away from the distal tip of the outer cannula towards the swivel neck plate as the residual air is removed by deflation.Do not use any sharp instruments such as forceps or hemostats that would damage the cuff when tapering it.¿ 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: 7969999
• Report Number: 8020889-2018-00095
• Device Sequence Number: 201415
• Product Code: JOH
• UDI-Device Identifier: 10884522027915
• UDI-Public: 10884522027915
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 80XLTCP
• Device Catalogue Number: 80XLTCP
• Device Lot Number: 201802084X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 115