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

Model Number	70XLTCD
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Extubate (2402)
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, two trach tubes were leaking and unable to maintain air in the balloon.The customer reported that there was no known patient involvement and outcome.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation.Visual examination shows no sign of any defect.The returned unit was inflated and leak tested under water.No leakage detected.The unit remained inflated for a four-hour period and no leakage was detected.The reported defect could not be detected on the unit returned for evaluation.The root cause of the reported defect could not be determined as no defect was detected on the unit returned for evaluation.All of our cuffed extended-length tracheostomy tubes(xlt) product undergo a four hour inflate/deflate test and it is at this stage of the process that any defect is removed from the lot.The product relates to the reported complaint event.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: 7468612
• Report Number: 8020889-2018-00048
• Device Sequence Number: 13761396
• Product Code: JOH
• UDI-Device Identifier: 20884522028162
• UDI-Public: 20884522028162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 10/01/2021
• Device Model Number: 70XLTCD
• Device Catalogue Number: 70XLTCD
• Device Lot Number: 201610052X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Other