MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; LABOR AND DELIVERY KIT

Model Number SMA7CVDYNH

Device Problem Component Missing (2306)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

While setting up a vaginal delivery table, the nurse noted there were only 4 rfid sponges present in the pack.She verified it with another registered nurse, who also only counted for rfid sponges.Lot number of the vaginal pack (sma7cvdynh) is lot# 924086.This rn notified management.

• Brand Name: CARDINAL HEALTH
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16156935
• MDR Text Key: 307274648
• Report Number: 16156935
• Device Sequence Number: 1
• Product Code: MLS
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SMA7CVDYNH
• Device Catalogue Number: SMA7CVDYNH
• Device Lot Number: 924086
• 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: 01/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female