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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 26000NS
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 product was dirty/stained.
 
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Brand Name
CHLORAPREP ONE-STEP
Type of Device
2% 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 Key10475049
MDR Text Key205474420
Report Number3004932373-2020-00033
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number26000NS
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/31/2020
Initial Date FDA Received08/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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