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

Model Number	80XLTCP
Medical Device Problem Code	Occlusion Within Device (1423)
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
Medtronic received a communication regarding a bubble preventing airflow.Customer reported that the patient had respiratory distress after the tracheostomy tube was changed.According to the reporter, a bubble was noted on the cuff of the tube covering the end preventing air flow through the tube.The customer indicated a tube had to be placed again.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.The returned unit was inflated using the parameters, however, air leaked rapidly from the main body of the cuff.Visual examination shows that there is a large bulge in the main body of the cuff.This type of damage is normally associated with over inflation of the cuff body.Further examination of the cuff body using the microvu shows that there is a slit in the main body of the cuff.The slit is clean cut measuring 1.3mm in length.This damage is indicative of coming in contact with a sharp utensil or object.The single wall thickness was measured and found to be within the blueprint specification.The root cause of the bulge on the cuff body is associated with over inflation of the cuff.The most probable root cause of the slit is contact with a sharp utensil or object.All of our cuffed 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.Instructions for use(ifu) under the section ¿warnings¿ states ¿under no circumstances should more than 25 mm of mercury (hg) air pressure be used to inflate the cuff.Over-inflation of the cuff may cause tracheal damage and may inhibit ventilation.Under the section ¿cautions¿ states ¿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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 6952329
• Report Number: 8020889-2017-05161
• Device Sequence Number: 1209204
• Product Code: JOH
• UDI-Device Identifier: 10884522027915
• UDI-Public: 10884522027915
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Model Number: 80XLTCP
• Device Catalogue Number: 80XLTCP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/16/2017
• 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: Required Intervention