MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CURITY; FIBER, MEDICAL, ABSORBENT

Model Number 2187

Device Problem Contamination (1120)

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

Event Date 10/06/2021

Event Type  malfunction  

Event Description

When opening a packet of sterile curity¿4x4 gauze sponges, there was something brown identified in the gauze.A second package of gauze was opened with a cluster of 3 brown particles.Gauze was not used on patient.

• Brand Name: CURITY
• Type of Device: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 12655919
• MDR Text Key: 277127705
• Report Number: 12655919
• Device Sequence Number: 1
• Product Code: FRL
• UDI-Device Identifier: 10884521058705
• UDI-Public: (01)10884521058705
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2187
• Device Catalogue Number: 2187
• Device Lot Number: D20122530S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1