MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANGIO TRAY

Catalog Number	DYNJ49372A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the operating (or) towel shed lint during an unidentified procedure.Per the facility, the linted material was discovered on the surgeon's hand and on a coronary interventional wire.It is unknown at what point in the procedure the reported towel linting occurred.Per the facility, there was no effect on patient stability.No impact to the procedure was reported.No serious injury, follow-up care, or medical intervention was reported.A sample was received by the manufacturer and the reported product issue was confirmed.Despite good faith efforts to obtain additional information, the facility contact was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Due the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the operating room (or) towel shed lint during an unidentified procedure.

• Common Device Name: ANGIO TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7444606
• Report Number: 1423395-2018-00015
• Device Sequence Number: 19113646
• Product Code: OEQ
• UDI-Device Identifier: 10889942167913
• UDI-Public: 10889942167913
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/19/2018

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: Physician
• Device Catalogue Number: DYNJ49372A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other