BD E-Z SCRUB
Received Nov 17, 2021 · Event occurred Aug 26, 2021
Report 1710034-2021-00960 · MDR key 12825295
Device
Product problems
- Unsealed Device Packaging
- Unsealed Device Packaging
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. REVIEW OF DEVICE HISTORY REVIEW DID NOT FIND ANY ATTRIBUTABLE DEFICIENCIES THAT WOULD LEAD TO THIS ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENT SHOWS THAT SEVERITY FOR STERILE PRODUCTS FOR LEAKING SEAL IS ACCEPTABLE WITH A REMOTE OCCURRENCE FOR THIS DEFECT AND PATIENT INFECTIONS/COMPLICATIONS BEING THE POTENTIAL FAILURE MODE. POSSIBLE CAUSES OF THIS ISSUE COULD BE RESULT OF INCORRECT SET UP OR REJECTED PRODUCT BEING INADVERTENTLY INTRODUCED BACK INTO THE PRODUCT STREAM. REVIEW OF THE BATCH RECORD SHOWS THAT PRODUCTION WAS PERFORMED AS SPECIFIED AND ALL IN-PROCESS QUALITY CHECKS MET ESTABLISHED SPECIFICATIONS. REVIEW OF LOT HISTORY SHOW NO NON-CONFORMANCE EVENTS ISSUED FOR THIS LOT. ROOT CAUSE FOR THIS ISSUE CANNOT BE ESTABLISHED AT THIS TIME. ANY FUTURE COMPLAINTS WILL CONTINUE TO BE MONITORED FOR THIS LOT AND ASSESSED. H3 OTHER TEXT : SEE NARRATIVE BELOW.
Description of Event or Problem
IT WAS REPORTED THAT THE PACK WAS OPENED. VERBATIM: DESCRIBE THE EVENT OR PROBLEM: BD E-Z SCRUB 160 SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER PACK WAS OPENED AND NOTED TO HAVE BLACK DEBRIS ON THE SPONGE.
Additional Manufacturer Narrative
PR (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 THE PACK WAS OPENED. DESCRIBE THE EVENT OR PROBLEM: BD E-Z SCRUB 160 SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER PACK WAS OPENED AND NOTED TO HAVE BLACK DEBRIS ON THE SPONGE.