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

Model Number SMA13CCEM4

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2021

Event Type  malfunction  

Event Description

From staff: during a c-section the certified surgical technician picked up a lap sponge off the table and the blue tag on the end came off.

• Brand Name: CARDINAL HEALTH
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11699862
• MDR Text Key: 246480646
• Report Number: 11699862
• 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: 04/15/2021,04/02/2021

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: SMA13CCEM4
• Device Catalogue Number: SMA13CCEM4
• Device Lot Number: 560257
• 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: 04/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 89