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

Model Number 44673

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

Insect found inside the sterile package.

• Brand Name: HALYARD
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): OM HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 16459769
• MDR Text Key: 310438637
• Report Number: 16459769
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10680651446739
• UDI-Public: (01)10680651446739(17)270926(10)AH2269TFG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 44673
• Device Catalogue Number: 44673
• Device Lot Number: AH2269TFG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1