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

Model Number SMA12SEMWV

Device Problems Break (1069); Decrease in Suction (1146)

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

Event Date 07/27/2019

Event Type  malfunction  

Event Description

During a cesarean section, there were problems getting the suction on the field to work properly.Despite changing the canisters 3 times there was still very weak suction.During closure of the uterus it was noted that the tip of the yankauer was not intact; it was jagged and appeared to have broken off.

• Brand Name: CARDINAL HEALTH
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8974820
• MDR Text Key: 156927870
• Report Number: 8974820
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMA12SEMWV
• Device Catalogue Number: SMA12SEMWV
• Device Lot Number: 538312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 119