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

Catalog Number SMA73VDS12

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

Vhs vag delivery pack on had 4 raytecs in it.There is suppose to be 10.Fda safety report id # (b)(4).

• 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: 14831276
• MDR Text Key: 294880691
• Report Number: MW5110529
• 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 Catalogue Number: SMA73VDS12
• Device Lot Number: 806095
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1