MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX REGULAR 4.7 LITER; BIOCIDES SOLUTIONS

Catalog Number	2266
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Disinfect (1175)
Health Effect - Clinical Code	HIV, Human Immunodeficiency Virus (2197)
Date of Event	07/22/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Advanced sterilization products (asp) became aware a patient tested (b)(6) for (b)(6) and was diagnosed in (b)(6) 2013 with acquired immune deficiency syndrome.It was reported a colonoscopy procedure was performed in (b)(6) 2011, using an olympus colonoscope (non-asp product) which was reprocessed in cidex solution.On (b)(6) 2004 (revised on (b)(6) 2004), ats labs prepared protocol # (b)(6) for asp, titled ¿virucidal efficacy of disinfectants for use on inanimate environmental surfaces ¿ virus: (b)(6) type 1¿.The conclusion of this study was that cidex demonstrated complete inactivation of (b)(6) type 1 as required by the united states (b)(4) for virucidal label claims.Asp made a decision to file a fda medwatch report out of an abundance of caution; however, asp does not believe the patient diagnosis was related to use of cidex during scope reprocessing.
Additional Manufacturer Narrative
No further information has been made available.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX REGULAR 4.7 LITER
• Common Device Name: BIOCIDES SOLUTIONS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7606148
• Report Number: 2084725-2018-00635
• Device Sequence Number: 1422579
• Product Code: LRJ
• UDI-Device Identifier: 10705037044580
• UDI-Public: 10705037044580
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K924434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability