MCKESSON

Additional Manufacturer Narrative

THE MCKESSON OPA/28 HLD SAFETY DATA SHEET STATES, "MAY CAUSE SKIN IRRITATION. SYMPTOMS MAY INCLUDE REDNESS, DRYING, DEFATTING AND CRACKING OF THE SKIN. MAY PRODUCE AN ALLERGIC SKIN REACTION." THE MCKESSON OPA/28 HLD INSTRUCTIONS FOR USE STATES, "CONTAINDICATIONS 1. MCKESSON OPA/28 SHOULD NOT BE USED TO REPROCESS ANY UROLOGICAL INSTRUMENTATION TO BE UTILIZED FOR CYSTOSCOPY OR OTHER UROLOGICAL PROCEDURES FOR PATIENTS WITH A HISTORY OF BLADDER CANCER. IN RARE INSTANCES SIMILAR ORTHO-PHTHALALDEHYDE (OPA) BASED DISINFECTANTS HAVE BEEN ASSOCIATED WITH ANAPHYLAXIS-LIKE REACTIONS IN BLADDER CANCER PATIENTS UNDERGOING REPEATED CYSTOSCOPIES." STERIS WAS NOTIFIED OF THE REPORTED EVENT BY THE DISTRIBUTOR. THE DISTRIBUTOR MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS FROM THE USER FACILITY; HOWEVER, ADDITIONAL INFORMATION WAS NOT PROVIDED. THE DISTRIBUTOR HAS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE MCKESSON OPA/28 HLD, SPECIFICALLY ON USE DURING CYSTOSCOPIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED ALLERGY SYMPTOMS FOLLOWING PROCEDURES WHICH INCLUDED USE OF CYSTOSCOPES REPROCESSED USING MCKESSON OPA/28 HLD. THE PATIENTS SOUGHT ADDITIONAL MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.