MAUDE Adverse Event Report: MEDLINE INDUSTRIES (NAMIC DIVISION) - GLEN FALLS NAMIC; CARDIOVASCULAR PROCEDURE KIT

Model Number	60180186
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found inside sterile supply package.

• Brand Name: NAMIC
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES (NAMIC DIVISION) - GLEN FALLS; 10 glen falls; technical park drive; glens falls NY 12801
• MDR Report Key: 20225264
• Report Number: 20225264
• Device Sequence Number: 3393067
• Product Code: OEZ
• UDI-Device Identifier: 10193489049381
• UDI-Public: (01)10193489049381(17)270119(10)0000109963
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024
• Report Date (Section F): 05/24/2024

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
• Device Model Number: 60180186
• Device Catalogue Number: 60180186
• Device Lot Number: 0000109963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/24/2024