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

Model Number	80XLTCD
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 80xltcd 8.0mm xlt trach cuff dist x1; 80xltcd 8.0mm xlt trach cuff dist x1; 80xltcd 8.0mm xlt trach cuff dist x1; 80xltcd 8.0mm xlt trach cuff dist x1.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the returned unit was contaminated and the cuff body came in contact with a sharp utensil or object.Functionally, the returned unit was inflated using the parameters set out in if001 and leak tested under water.Air leaked rapidly from the main body of the cuff.Further examination of the cuff body using the microvu shows that there was a clean cut slit in the main body of the cuff measuring 1.3mm in length.This type of damage was indicative of the cuff body coming in contact with sharp utensil or object.The single wall thickness of the cuff was measured away from the damaged area and found to be within the blueprint specification.It was reported that the cuff of the trach tubes "ruptured" four times.It was also stated that other tubes only hold pressure for 15 minutes and then lose air which the reporter thought to be related to the pilot spring.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.
Event or Problem Description
According to the reporter, the cuff of the trach tubes "ruptured" four times.It was also stated that other tubes only hold pressure for 15 minutes and then lose air which the reporter thought to be related to the pilot spring.A hole was also found on the failed cuff.Replacement of the tube was done.One device was returned with no failure reported but medtronic's initial evaluation of the incident device found that air leaked rapidly from the main body of the cuff and there is a clean cut slit in the main body of the cuff measuring 1.3mm in length.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17241340
• Report Number: 8020889-2023-00129
• Device Sequence Number: 4795492
• Product Code: JOH
• UDI-Device Identifier: 20884522028179
• UDI-Public: 20884522028179
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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: 80XLTCD
• Device Catalogue Number: 80XLTCD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H10
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 135 KG