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

Model Number	86548-
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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, during patient intubation, the device was found to have a broken cuff.There was no patient harm.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 13112842
• Report Number: 8020889-2021-00177
• Device Sequence Number: 3605680
• Product Code: BTR
• UDI-Device Identifier: 10884521211919
• UDI-Public: 10884521211919
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K790575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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: 03/01/2026
• Device Model Number: 86548-
• Device Catalogue Number: 86548-
• Device Lot Number: 202103162X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/29/2021
• Date Device Manufactured: 03/08/2021
• 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
• Patient Sex: Unknown