BD E-Z SCRUB
Received Sep 21, 2021 · Event occurred Aug 27, 2021
Report 1710034-2021-00831 · MDR key 12506374
Device
Product problems
- Microbial Contamination of Device
- Microbial Contamination of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT SPONGE BRUSH SCRUB APPEARS TO HAVE MOLD ON THE BRUSH. VERBATIM: WE HAD THE FOLLOWING ISSUE- DO WE NEED TO PULL THIS LOT? WE STILL HAVE THE ITEM. "WHEN IT WAS OPENED IN A CASE AND IT APPEARS TO HAVE MOLD ON THE SCRUB BRUSH. LOT NUMBER 0328903" CUSTOMER NOTIFIED ME BY EMAIL ON (B)(6) 2021 OF THIS ISSUE. AND IN THE E-MAIL SAID THEY STILL HAVE THE PRODUCT ITEM. CUSTOMER IS ALSO ASKING WHAT SHOULD THEY DO WITH THE FOLLOWING SCRUB BRUSHES WITH THE SAME LOT#! I BELIEVE THIS EVENT OCCURRED ON (B)(6) 2021 AS THIS IS WHEN I WAS NOTIFIED.
Additional Manufacturer Narrative
CAUSE OF THE FOREIGN MATTER IS LIKELY A DEFECTIVE SECTION OF THE FOAM SPONGE (BURNT SPONGE) PER THE FTIR ANALYSIS PERFORMED. BATCH RECORD WAS REVIEWED, INCLUDING ALL ATTRIBUTE DATA, AND NO DEVIATIONS OR DISCREPANCIES WERE NOTED THAT WOULD CONTRIBUTE OR CAUSE THIS ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENT SHOWS THAT SEVERITY RATING IS MINOR FOR THIS DEFECT. THIS IS THE FIRST COMPLIANT REPORTED FOR THIS LOT. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED. NO CAPA REQUIRED. H3 OTHER TEXT : SEE NARRATIVE BELOW.
Additional Manufacturer Narrative
(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SPONGE BRUSH SCRUB APPEARS TO HAVE MOLD ON THE BRUSH. ¿ VERBATIM: WE HAD THE FOLLOWING ISSUE- DO WE NEED TO PULL THIS LOT? WE STILL HAVE THE ITEM. "WHEN IT WAS OPENED IN A CASE AND IT APPEARS TO HAVE MOLD ON THE SCRUB BRUSH. LOT NUMBER 0328903" CUSTOMER NOTIFIED ME BY EMAIL ON 8/27 OF THIS ISSUE. AND IN THE E-MAIL SAID THEY STILL HAVE THE PRODUCT ITEM. CUSTOMER IS ALSO ASKING WHAT SHOULD THEY DO WITH THE FOLLOWING SCRUB BRUSHES WITH THE SAME LOT#! I BELIEVE THIS EVENT OCCURRED ON 8/27 AS THIS IS WHEN I WAS NOTIFIED.