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

Catalog Number SMA73VDSVJ

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Pack only had 9 raytecs instead of 10.Vaginal delivery pack only had 9 raytecs instead of 10.

Event Description

Pack only had 9 raytecs instead of 10.Vaginal delivery pack only had 9 raytecs instead of 10.

• Brand Name: CARDINAL HEALTH VHS VAG DELIVERY PACK
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 13584078
• MDR Text Key: 286082706
• Report Number: MW5107608
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: SMA73VDSVJ
• Device Lot Number: 721942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1