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

Catalog Number SMA73VDS15

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Vhs vag delivery pack contained only 9 raytecs.The par level is 10.This is a patient safety issue.Fda safety report id # (b)(4).

• Brand Name: CARDINAL HEALTH PROSOURCE
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; waukegan IL 60085
• MDR Report Key: 15562866
• MDR Text Key: 301559911
• Report Number: MW5112490
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMA73VDS15
• Device Lot Number: 887995
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1