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

Model Number	18775
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/16/2017
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 representative, during the cuff test, it was found that the cuff leaked air.The customer indicated that there was no patient involvement associated to this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: (eval - code conclusion).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: one sample was received for evaluation and the reported condition was confirmed.An inflation deflation test was performed and it was observed the cuff deflated immediately.A visual inspection was performed and it was observed the cuff has a small cut.Additional investigation is ongoing.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 1181 desarrol; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 7097761
• Report Number: 2936999-2017-05661
• Device Sequence Number: 16369596
• Product Code: BTR
• UDI-Device Identifier: 60884522007608
• UDI-Public: 60884522007608
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2018

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: 12/21/2021
• Device Model Number: 18775
• Device Catalogue Number: 18775
• Device Lot Number: 16L0669JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 02/01/2018; 02/20/2018; 03/20/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 02/15/2018; 03/20/2018; 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1