MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; D AND C TRAY

Model Number SMA13DCEMP

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

From staff: sponges from a pack found to have debris/bug.

• Brand Name: CARDINAL HEALTH
• Type of Device: D AND C TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17360684
• MDR Text Key: 319396569
• Report Number: 17360684
• Device Sequence Number: 1
• Product Code: PKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SMA13DCEMP
• Device Catalogue Number: SMA13DCEMP
• Device Lot Number: 037744
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1