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

Model Number	86113
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that prior to use on a patient, a piece of hair was found contained in the package.It was reported that there was no patient involvement.
Additional Manufacturer Narrative
The sample was received for analysis.A visual inspection was performed and the reported event was confirmed.The reported customer event is a known issue and root cause investigation efforts have been addressed in a corrective and preventative action.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that prior to use on a patient, a piece of hair was found contained in the package.It was reported that there was no patient involvement.

• 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: 6671562
• Report Number: 2936999-2017-05299
• Device Sequence Number: 13505493
• Product Code: BTR
• UDI-Device Identifier: 60884522000135
• UDI-Public: 60884522000135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 11/08/2021
• Device Model Number: 86113
• Device Catalogue Number: 86113
• Device Lot Number: 16K0307JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1