MAUDE Adverse Event Report: MALLINCKRODT MEDICAL MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	110875
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
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 had cuff inflation/deflation issue.The customer indicated that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: three samples returned for evaluation two contained in their original opened unit packs and one in a plastic bag.Visual examination of the two unused samples shows no sign of any defect.Both units were inflated.Both units inflated/deflated without any issue.The samples were inflated/deflated three times without any restriction noted.Examination of the remaining sample confirms that the unit is contaminated.The sample was inflated however it deflated rapidly.The sample was leak tested under water and leakage was noted from the inflation line.Further examination of the inflation line shows that there are two slits in the main body of the inflation line.One slit is clean cut measuring 1.4mm, the second slit is clean ¿c¿ shaped cut with the material still attached to the main body of the inflation line.This slit measures 2.4mm in length.The damage detected is indicative of coming in contact with a sharp utensil or object.The reported defect could be detected on one unit returned for evaluation only.The most probable root cause is the inflation line came in contact with a sharp utensil or object.All of our product under goes a four hour inflate/deflate test and it is at this stage of the process that any defects are removed from the lot.The defect detected on the unit returned for evaluation would not have passed this inspection.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.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8706165
• Report Number: 8020889-2019-00066
• Device Sequence Number: 2386371
• Product Code: BTR
• UDI-Device Identifier: 30884521068227
• UDI-Public: 30884521068227
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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 Expiration Date: 01/01/2024
• Device Model Number: 110875
• Device Catalogue Number: 110875
• Device Lot Number: 201901361X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1