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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

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CAREFUSION, INC CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number 260815NS
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).

 
Event Description

It was reported that particulate was found. Lot affected: 0006142, 0041225 and 0041224.

 
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Brand NameCHLORAPREP ONE-STEP
Type of Device2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
Manufacturer (Section D)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
8015652341
MDR Report Key10475098
MDR Text Key205347744
Report Number3004932373-2020-00035
Device Sequence Number1
Product Code KXF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number260815NS
Device LOT NumberMULTIPLE LOTS AFFECTED
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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