BD E-Z SCRUB
Received Dec 21, 2020 · Event occurred Dec 11, 2020
Report 1710034-2020-00801 · MDR key 11045892
Device
Generic name
Chlorahexidine Gluconate Solution
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
377479
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Irritation
- Irritation
Narrative
Additional Manufacturer Narrative
(B)(6) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE OR LOT NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENTS ARE EXPERIENCING SKIN REDNESS, PEELING, AND ITCHING AFTER BRUSHING.