MAUDE Adverse Event Report: OM HALYARD, INC. HALYARD; DRAPE, SURGICAL

Model Number	40992
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medline poly-cath suction catheter size 14f was found in sterile core of main or with 10 inches of strike through sterile packaging.

• Brand Name: HALYARD
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): OM HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• MDR Report Key: 13666374
• Report Number: 13666374
• Device Sequence Number: 4893645
• Product Code: KKX
• UDI-Device Identifier: 10680651409925
• UDI-Public: (01)10680651409925
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2022
• Report Date (Section F): 02/22/2022

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: Other
• Device Model Number: 40992
• Device Catalogue Number: 40992
• Device Lot Number: 48620100001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2022
• 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: 02/22/2022