MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CESAREAN SECTION PACK; CESAREAN SECTION TRAY

Model Number SMA12CSMFO

Device Problems Material Separation (1562); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

The surgeon observed a defect in the c-section drape.When the protective paper was pulled away from the sticky portion of the drape, approximately four inches was separated along the margin.Drape sterility was not affected, but the seal to prevent fluid from draining on the or bed and patient was compromised.A tegaderm was placed over the separated portion, so fluid would drain into the collection bag built into the drape.The drape was used for the procedure.

• Brand Name: CESAREAN SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14944185
• MDR Text Key: 295408618
• Report Number: 14944185
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2022

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
• Device Operator: Other
• Device Model Number: SMA12CSMFO
• Device Catalogue Number: SMA12CSMFO
• Device Lot Number: 800872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female