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

Catalog Number SMA40DERWC

Device Problems Packaging Problem (3007); Component Misassembled (4004)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Irregular count of raytex sponges in vaginal delivery pack.

• Brand Name: CARDINAL HEALTH VAGINAL DELIVERY PACK
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 16809566
• MDR Text Key: 314009950
• Report Number: MW5117002
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMA40DERWC
• Device Lot Number: 85440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic