BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES WERE CONTAMINATED WHEN OPENED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

Additional Manufacturer Narrative

DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. RETURNED SAMPLE CONFIRMS THE PRESENCE OF FOREIGN AS INDICATED IN THE RETURNED PHOTOS. DHR REVIEW DID NOT SHOW ANYTHING RELATED TO FOREIGN MATTER. DURING PACKAGING EXCESS FILM MATERIAL IS TRIMMED FROM THE EDGE OF THE MULTIVAC MACHINE AND REMOVED FROM THE PROCESS BY VACUUM. THIS HAPPENS AFTER THE PACKAGE HAS BEEN SEALED. THE FOREIGN IS MUCH THINNER THAN THE NORMAL TRIM. FROM THE ASSOCIATED DIRT, IT WAS LIKELY TO HAVE BEEN CAUGHT IN THE MULTIVAC¿S DRIVE CHAIN AND THEN BEEN PULLED UNDER THE MACHINE AND RELEASED AT A POINT BEFORE THE PACKAGE WAS SEALED. THIS IS AN INFREQUENT COMPLAINT OF LOW SEVERITY. NOTE THAT THE PRODUCT IS TERMINALLY STERILIZED AND THAT THE FOREIGN, ALTHOUGH UNSIGHTLY, WOULD HAVE POSED NO INFECTION RISK TO THE END USER.

Description of Event or Problem

IT WAS REPORTED THAT THE BD E-Z SCRUB PREOPERATIVE SURGICAL SCRUB BRUSHES WERE CONTAMINATED WHEN OPENED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.