MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI-LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number NS272715

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that there was leakage.Verbatim: the chloraprep 10,5 ml applicators in the carton have partially leaked and have discolored the packaging of the other applicators.The outer carton was not damaged.

Manufacturer Narrative

Photos were available for evaluation.Photos show orange dye coloration around the tinted orange pledget inside the barrel and on the back side of the foam tip which verifies the reported issue of stain in foam, not leakage.The area around the orange tinted pledget will tend to be reddish/orange due to the ultrasonic welding process of the foam tip unto the body/handle disperses the orange dye in the pledget to proximity area.This type of red/orange dye is acceptable around the tinted orange pledget inside the applicator barrel and on the back side of the foam tip but is considered a cosmetic defect when the orange dye extends throughout the barrel or on front of the foam tip (scrubbing surface).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.Also, 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.A production record review was completed for batch/lot 1081688 and no non conformances were identified during the manufacturing of this lot.No further actions are required.This failure will continue to tracked and trended.

Event Description

It was reported that there was leakage.Verbatim: the chloraprep 10,5 ml applicators in the carton have partially leaked and have discolored the packaging of the other applicators.The outer carton was not damaged.

• 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 Key: 13734838
• MDR Text Key: 287036984
• Report Number: 3004932373-2022-00070
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: NS272715
• Device Lot Number: 1081688
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other