MAUDE Adverse Event Report: CAREFUSION BD CHLORAPREP SCRUB TEAL 10.5ML APPLICATOR; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Model Number 930725

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

Sterile chloraprep stick with a visible hair in the package.Item was removed and no other packages with this defect were found in the bin at this time.

• Brand Name: BD CHLORAPREP SCRUB TEAL 10.5ML APPLICATOR
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 17077854
• MDR Text Key: 317216945
• Report Number: 17077854
• Device Sequence Number: 1
• Product Code: KXF
• 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: 06/06/2023

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: 930725
• Device Catalogue Number: 930725
• Device Lot Number: L2351409
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1