MAUDE Adverse Event Report: MEDLINE INDUSTRIES TR-SEPTO-RHINOPLASTY PK-LF; CUSTOM SURGICAL PACK

Catalog Number	DYNJ0396069F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After procedure started, a hair was found in the pack on the outside of the basin.The surgical team was made aware.This did not reach the patient, however, it was not saved since the procedure was already progressing, and staff needed to work quickly to replace supplies.Per site reporter: the field representative was notified and he will open a complaint with medline's quality team.

• Brand Name: TR-SEPTO-RHINOPLASTY PK-LF
• Common Device Name: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline pl.; mundelein IL 60060
• MDR Report Key: 7337320
• Report Number: 7337320
• Device Sequence Number: 19029149
• Product Code: LRO
• UDI-Device Identifier: 10889942065714
• UDI-Public: (01)10889942065714
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018
• Report Date (Section F): 03/09/2018

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: No Information
• Device Catalogue Number: DYNJ0396069F
• Device Lot Number: 17LD1056
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 106
• Date Report Sent to FDA: 03/09/2018