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 930815

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

**#7- srg-ip defective product- clora-prep ( leaking ); credit only.(b)(4).1-ea material # 930815hello team, good day may we seek assistance for credit or return of a defective item." defective product- clora-prep ( leaking ); (b)(4) item - 930815 1ea your assistance is highly appreciated thank you, (b)(6).(b)(4).Customer support services phone: 800.964.5227 | fax: 866.303.6710 (b)(4).Did you know you can use cardinal health market to: (b)(4)-customersupport <(b)(4)-customersupport@cardinalhealth.Com> cc: sent: 02/03/2022 14:48:20 subject: action required: customer (b)(4) defective items cardinal health products & services.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A sample was provided for evaluation.Visual examination of the sample shows small orange dot/specs on the lidding verifying the reported issue.The orange dye is not of foreign matter but is a 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 dye is used on the applicator as part of the design to color the solution upon activation by breaking the ampoule and solution flowing thru the hi-lite orange pledget (with the orange dry powder dye) as a visual prepping confirmation on the patient¿s skin.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.No production record review was completed as the batch/lot information was unavailable.No further actions are required at this time.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that product is leaking.Verbatim: **#7- srg-ip defective product- clora-prep ( leaking ); credit only (b)(4).Hello team, good day may we seek assistance for credit or return of a defective item." defective product- clora-prep ( leaking ); (b)(4).Item - 930815 1ea.Your assistance is highly appreciated.

• 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: 13670239
• MDR Text Key: 296239475
• Report Number: 3004932373-2022-00065
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other