MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	86398
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 device had leaked pilot balloon.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation contained in a plastic bag.The distal cuff inflated however the proximal cuff deflated rapidly.The returned was placed under water and air syringed though the proximal inflation system.Air leaked from the distal end of the tubing.Visual examination of the distal end of the tubing shows that the proximal secondary lumen close off does not meet the required 2mm close off.The reported defect could be detected on the unit returned for evaluation.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure to the cuff deflation.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: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8593080
• Report Number: 2936999-2019-00330
• Device Sequence Number: 2014785
• Product Code: BTR
• UDI-Device Identifier: 10884522002066
• UDI-Public: 10884522002066
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K873461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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 Model Number: 86398
• Device Catalogue Number: 86398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1