STERRAD® 100NX CASSETTE

Description of Event or Problem

A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) IN HER FIFTIES EXPERIENCED A ¿LOW-TEMPERATURE BURN¿ WHEN SHE OPENED A NEW STERRAD® 100NX CASSETTE PACKAGE. THE HCW WAS WEARING WATERPROOF GLOVES, BUT SHE DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE HYDROGEN PEROXIDE LEAKED DOWN HER ARM AND THE SKIN TURNED WHITE. SHE WASHED THOROUGHLY WITH RUNNING WATER AND THE H2O2 SKIN REACTION LASTED ONE DAY. SHE DID NOT RECEIVE MEDICAL ATTENTION, AND IT WAS REPORTED SHE ¿TOTALLY RECOVERED¿. THE H2O2 ¿LOW-TEMPERATURE BURN" WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

Additional Manufacturer Narrative

H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE BATCH RECORD, RETAINS TESTING, ANALYSIS OF PICTURES, TRENDING ANALYSIS BY LOT NUMBER, AND SYSTEM RISK ANALYSIS (SRA). ¿ THE BATCH HISTORY RECORD WAS REVIEWED AND NO ISSUES RELATING TO THE FAILURE MODE WERE NOTED. THE LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. ¿ RETAINS TESTING WAS COMPLETED WITH NO ISSUES IDENTIFIED; THE RETAIN SAMPLES WERE WITHIN SPECIFICATIONS. ¿ VISUAL INSPECTION OF FIELD SAMPLE PICTURES CONFIRM THE CASSETTE'S CELL NUMBER 2 WAS HALF EMPTY. ¿ TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FOR THE SIX MONTHS PRIOR TO OPEN DATE AND TRENDING WAS NOT EXCEEDED. ¿ REVIEW OF RISK DOCUMENTATION SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE STERRAD® 100NX CASSETTE WAS NOT RETURNED FOR FURTHER EVALUATION. THE SKIN REACTION HAS BEEN ATTRIBUTED TO USER ERROR AS THE HEALTHCARE WORKER (HCW) WAS NOT USING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) WHILE OPENING A NEW STERRAD® 100NX CASSETTE PACKAGE. THE CUSTOMER WAS RE-TRAINED TO ALWAYS WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN HANDLING CASSETTES. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ASP COMPLAINT REF #: (B)(4).

Additional Manufacturer Narrative

ADVANCED STERILIZATION PRODUCTS (ASP) HAS INVESTIGATED THE COMPLAINTS TO SUPPORT THE RATIONALE FOR THE DECISION TO CEASE REPORTING USER ERROR EVENTS ASSOCIATED WITH HANDLING STERRAD 100NX CASSETTE USED WITH STERRAD 100NX STERILIZERS. THE ISSUE IS INDICATED IN THE PRODUCT LABEL WARNING AS A KNOWN RISK IF PERSONAL PROTECTIVE EQUIPMENT (E.G. GLOVES) ARE NOT WORN. THE PROBABILITY OF SERIOUS ADVERSE HEALTH CONSEQUENCES IS REMOTE; THEREFORE, ASP HAS DETERMINED THAT THE USE ERROR/MALFUNCTION IS NO LONGER LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS ADVERSE EVENT IF IT WERE TO RECUR. ASP HAS NOTIFIED THE U.S. FOOD AND DRUG ADMINISTRATION OF THE CEASE MALFUNCTION REPORTING DECISION, REFERENCE FDA DOCUMENT NUMBER (B)(4). ASP COMPLAINT REF #: (B)(4).