BD E-Z SCRUB
Received May 4, 2023 · Event occurred Apr 27, 2023
Report 1710034-2023-00466 · MDR key 16870484
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Rash
- Rash
Narrative
Additional Manufacturer Narrative
PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E1714. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A24.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT ONE OF NURSE'S COLLEAGUES DEVELOPED A RASH ON ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. VERBATIM: QUESTION: NURSE WANTING TO KNOW IF THERE ARE ANY ACCELERANTS IN THE EZ SCRUB BRUSH (REF 371603, LOT# 3214288).STATES ONE OF HER COLLEAGUES DEVELOPED A RASH ON HIS ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUB BRUSH OR THE GOWN HE WAS WEARING. RESPONSE: EXPLAINED 371603 DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. INFORMED THE SPONGE ISMADE OF POLYURETHANE, THE HOLDER IS MADE OF POLYPROPYLENE, AND THE BRISTLES OF THE BRUSH ARE POLYETHELYNE.THE NAIL PICK IS MADE OF HIGH DENSITY POLYETHTLENE.
Additional Manufacturer Narrative
NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THE SUSPECTED PRODUCT DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. THE SPONGE, HOLDER, BRUSH BRISTLES AND THE NAIL PICK ARE ALL MADE OF POLYURETHANE. THESE INGREDIENTS DO NOT HAVE AN ADHERENT CORRELATION TO ANY ALLERGIC REACTIONS BD HAS INVESTIGATED IN THE PAST. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT ONE OF NURSE'S COLLEAGUES DEVELOPED A RASH ON ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. VERBATIM: QUESTION NURSE WANTING TO KNOW IF THERE ARE ANY ACCELERANTS IN THE EZ SCRUB BRUSH (REF (B)(4), LOT# 3214288).STATES ONE OF HER COLLEAGUES DEVELOPED A RASH ON HIS ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. RESPONSE EXPLAINED 371603 DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. INFORMED THE SPONGE IS MADE OF POLYURETHANE, THE HOLDER IS MADE OF POLYPROPYLENE, AND THE BRISTLES OF THE BRUSH ARE POLYETHYLENE. THE NAIL PICK IS MADE OF HIGH DENSITY POLYETHYLENE.