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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 Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
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 there were flecks of chloraprep on the inside of the packaging.Verbatim: healthcare professional called to report that there are flecks of chloraprep inside the package.May have come from the belt as it was coming across.4 diff lots.Nothing on the sponge that has been popped.Still in good condition.Dont see it until opening the package and then see the spots on the inside of the package.When asked if there was any evidence of the ampoule being broken? could glass shards be seen when held up to a light or heard when shaken? she answered no.
 
Manufacturer Narrative
Samples were provided for evaluation.The samples showed small orange dot/specs on the lidding verifying the reported issue.The orange dye is not of foreign matter origin, but is an inactive ingredient inherit in the product by design.The orange dye powder may be dispersed to the outside of the applicator on rare occasions during the assembly, and packaging.During the sterilization which uses vapor (water), when in contact with the orange dye brings out exaggerates the orange color intensity.The orange color inside the package does not indicate the product has been activated, leaking, or is dirty (foreign matter).The applicator is sterile if package is intact.The most probable root cause for orange dye around the orange tinted pledget is the equipment, process and / or material variability inherent to the process and design.The production record review was completed for batch/lot 1187105 and no non-conformance was noted during the manufacturing of this lot.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.
 
Event Description
It was reported that there were flecks of chloraprep on the inside of the packaging.Verbatim: healthcare professional called to report that there are flecks of chloraprep inside the package.May have come from the belt as it was coming across.4 diff lots.Nothing on the sponge that has been popped.Still in good condition.Dont see it until opening the package and then see the spots on the inside of the package.When asked if there was any evidence of the ampoule being broken? could glass shards be seen when held up to a light or heard when shaken? she answered no.
 
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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
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 Key12729026
MDR Text Key279607459
Report Number3004932373-2021-00484
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number930815
Device Lot Number1187105
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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