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 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Samples were returned for evaluation.Visual examination of the samples show small orange dot/specs on the lidding which verifies the reported issue.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 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 or rare occasions during assembly and/or packaging.During sterilization which uses vapor (water), when in contact with the orange dye bring 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 through the hi-lite orange pledget as a visual prepping confirmation on the patient's skin.The orange color inside the package does not indicate the package does not indicate the product has been activated, leaking, or is dirty (foreign matter).A production record review for batches/lots 1202964, 1194711, 1183209 and 1177224 was completed and no non-conformance was noted during the manufacturing of these lots.No further action will be taken and bd will continue to track & trend.

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.Lots 1202964, 1194711, 1183209.1177224.

• 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: 12728924
• MDR Text Key: 279607299
• Report Number: 3004932373-2021-00483
• 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: distributor,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 1177224
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other