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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 260299
Device Problem Defective Component (2292)
Patient Problem Laceration(s) (1946)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
 
Event Description
A lab tech went to draw a ob patient for blood cultures.She used the chloraprep pictured.The patient complained of pain when she used the chloraprep.Lab tech then noticed blood on the patients arm, and on the techs finger.Apparently the cylinder inside came through the foam and cut the patient.
 
Event Description
A lab tech went to draw a ob patient for blood cultures.She used the chloraprep pictured.The patient complained of pain when she used the chloraprep.Lab tech then noticed blood on the patients arm, and on the techs finger.Apparently the cylinder inside came through the foam and cut the patient.
 
Manufacturer Narrative
2 photos have been provided for evaluation.One shows the lidding side of the packaging and the other shows the applicator foam side.Based on the review of these photos,, no broken or presence of sharpness can be observed that verifies the reported defect.Unfortunately, as a result, no potential root cause can be defined and no corrective actions are required at this time.This failure mode will continue to be tracked and trended.
 
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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
MDR Report Key10515473
MDR Text Key206497293
Report Number3004932373-2020-00041
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number260299
Device Lot Number0087065
Date Manufacturer Received08/26/2020
Patient Sequence Number1
Patient Outcome(s) Other;
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