MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HALYARD C-SECTION PACK; C-SECTION KIT

Catalog Number 89-9416.03

Device Problems Device Contamination with Body Fluid (2317); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

After a schedule cesarian section case, the physician scrub was soaked/soiled with body fluid.The surgical gowns are normally impermeable.It is unknown why this particular gown was defected.Manufacturer response for c-section pack, halyard (per site reporter).Response from the manufacturer is pending.

• Brand Name: HALYARD C-SECTION PACK
• Type of Device: C-SECTION KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 10142456
• MDR Text Key: 194845768
• Report Number: 10142456
• Device Sequence Number: 1
• Product Code: OHM
• 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: 06/10/2020

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 Operator: No Information
• Device Catalogue Number: 89-9416.03
• Device Lot Number: 52175574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1