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

Model Number	18770
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2018
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, prior to use, the inflated cuffed leaked the air.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Additional information: evaluation summary: one sample was received for evaluation and the reported issue was confirmed.An inflation/deflation test was performed and inspects all products for no leaks and segregates the defective parts.No root cause was determined.The device history record (dhr) was reviewed and no discrepancies were found.All manufacturing controls were found acceptable and effective to detect the reported failure mode.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,ci 32590 ; MX 32590
• MDR Report Key: 7405204
• Report Number: 2936999-2018-00246
• Device Sequence Number: 10943561
• Product Code: BTR
• UDI-Device Identifier: 60884522007592
• UDI-Public: 60884522007592
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 01/18/2022
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 17A0386JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1