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

Catalog Number SMA73VDS11

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Vhs vag delivery pack only had 9 raytecs.The pack is suppose to come with 10.Fda safety report id # (b)(4).

• Brand Name: CARDINAL HEALTH
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 14831348
• MDR Text Key: 294880578
• Report Number: MW5110531
• Device Sequence Number: 1
• Product Code: MLS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMA73VDS11
• Device Lot Number: 780589
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1