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

Model Number	18750
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report a piece of hair was found contained in the package.Customer indicated issue was found prior to patient use.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.A visual inspection was performed and the presence of a s trand of hair was observed inside the sealed pouch.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.
Event or Problem Description
Medtronic received a report a piece of hair was found contained in the package.Customer indicated issue was found prior to patient use.

• 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: 6528587
• Report Number: 2936999-2017-05159
• Device Sequence Number: 13674267
• Product Code: BTR
• UDI-Device Identifier: 30884522007539
• UDI-Public: 30884522007539
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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: 03/03/2021
• Device Model Number: 18750
• Device Catalogue Number: 18750
• Device Lot Number: 16C0164JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1