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

Model Number	80XLTCP
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	11/13/2017
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
Manufacturer received a communication regarding a cuff that would not inflate.The customer reported that this occurred while the doctor was trying to install a new tube on the patient but it was stated that no harm occurred.However, additional information was received as the representative informed that recannulation was required.
Additional Manufacturer Narrative
One sample returned for evaluation and the reported condition was confirmed.An attempt made to inflate the returned failed.Further examination of the returned unit shows that there is damage to the inflation line.Examination of the inflation line shows that there are two jagged like markings on the inflation line which is indicative of contact with a clamp.The most probable root cause is the inflation line came in contact with a sharp utensil or object.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: 7081238
• Report Number: 8020889-2017-05196
• Device Sequence Number: 11212253
• Product Code: JOH
• UDI-Device Identifier: 10884522027915
• UDI-Public: 10884522027915
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: 04/18/2018
• Device Model Number: 80XLTCP
• Device Catalogue Number: 80XLTCP
• Device Lot Number: 201304272X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 04/20/2018
• 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