MAUDE Adverse Event Report: MMJ, S.A. DE C.V.(USD) MALLINCKRODT; AIRWAY, NASOPHARYNGEAL

Model Number	8888247056
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/12/2018
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 the reporter, prior to use, the device had chinese label issue.It was stated that 3 boxes of the received device were showing different manufacturing date.The customer indicated no patient involvement.

• Brand Name: MALLINCKRODT
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• Manufacturer (Section D): MMJ, S.A. DE C.V.(USD); ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7465060
• Report Number: 2936999-2018-00308
• Device Sequence Number: 1543085
• Product Code: BTQ
• UDI-Device Identifier: 60884521133124
• UDI-Public: 60884521133124
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K760125
• 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
• Report Date (Section B): 04/26/2018

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: 12/07/2022
• Device Model Number: 8888247056
• Device Catalogue Number: 8888247056
• Device Lot Number: 17L0201JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1