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

Model Number	76270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was a foreign material inside the tube.There was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation outside its pouch.This product is used in treatment.A visual inspection was performed, and no foreign material was observed in the tube.No failure mode was observed in the received sample and the product meets specification as well as all manufacturing controls were found acceptable and effective to detect the reported event.No root cause was determined and the reported event was not confirmed.This case was reviewed by manufacturing quality and presented to the corrective action board it has been determined that this event will be monitored but no corrective action is required at this time.Device history record was reviewed and no discrepancies were found.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: 7199107
• Report Number: 8020889-2018-00007
• Device Sequence Number: 13682458
• Product Code: BTR
• UDI-Device Identifier: 40884521157393
• UDI-Public: 40884521157393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K941246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: 06/21/2022
• Device Model Number: 76270
• Device Catalogue Number: 76270
• Device Lot Number: 17F0428JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1