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

Model Number	18770
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the cuff test, it was found that the cuff leak the air.There was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation and the reported event that an air leak was noted in the cuff.The product was used for treatment.A visual inspection was performed, and it was observed the cuff presented a small cut.The product did not meet specification.The device history record (dhr) was reviewed and no discrepancies were found.Information has been added to the database and trends will continue to be monitored.Correction: (name, email), (phone).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: 7180483
• Report Number: 2936999-2018-00024
• Device Sequence Number: 877616
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 10/25/2021
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 16J0677JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1