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U.S. Department of Health and Human Services

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

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ADVANCED STERILIZATION PRODUCTS CIDEX REGULAR 4.7 LITER BIOCIDES SOLUTIONS Back to Search Results
Catalog Number 2266
Device Problems Device Reprocessing Problem (1091); Failure to Disinfect (1175)
Patient Problem HIV, Human Immunodeficiency Virus (2197)
Event Date 07/22/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event 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.
 
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Brand NameCIDEX REGULAR 4.7 LITER
Type of DeviceBIOCIDES SOLUTIONS
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer Contact
gabriel alfageme
33 technology drive
irvine, CA 92618
949789-868
MDR Report Key7606148
MDR Text Key111212957
Report Number2084725-2018-00635
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K924434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2266
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/15/2018 Patient Sequence Number: 1
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