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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI-LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
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CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI-LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number 930815
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 08/12/2021
Event Type  Injury  
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 by the sales representative that the patients are experiencing rashes.My name is [omitted], reached out to me today informing me about a problem they have had with chloraprep.[omitted], supply chain specialist, informed me that 4 different surgeons reported to him that they noticed a rash had formed on their patients after using the 26ml hi-lite orange chloraprep.I am working with him to find out user technique.But i wanted to report this problem.Please let me know if there is anything else you need.
 
Manufacturer Narrative
No additional information was provided by (b)(6) hospital - livingston.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.H3 other text : see narrative below.
 
Event Description
It was reported by the sales representative that the patients are experiencing rashes.My name is [omitted], reached out to me today informing me about a problem they have had with chloraprep.[omitted], supply chain specialist, informed me that 4 different surgeons reported to him that they noticed a rash had formed on their patients after using the 26ml hi-lite orange chloraprep.I am working with him to find out user technique.But i wanted to report this problem.Please let me know if there is anything else you need.
 
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Brand Name
CHLORAPREP ONE STEP HI-LITE ORANGE
Type of Device
2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
Manufacturer (Section D)
CAREFUSION 213, LLC 0113
1550 northwestern dr
el paso TX 79912
MDR Report Key12365991
MDR Text Key268084597
Report Number3004932373-2021-00416
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number930815
Device Lot NumberUNKNOWN
Date Manufacturer Received10/05/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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