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

Catalog Number 930815

Device Problem Defective Device (2588)

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

Event Date 08/04/2021

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 by the sales representative that the solution spilled/leaked within the package.It appears a few chloraprep packages with the solution spilled/leaked within in the package, but the prep stick has not been cracked.They are concerned whether or not this compromises the sterility/integrity of the prep stick.Per response email: it had appeared both prep sticks had not been cracked.I did not try shaking them or holding them up to a light.Both of the prep sticks in question were sent back with the shipping label provided by bd.

Manufacturer Narrative

The samples showed small orange dots on the lidding.The orange dye is not or 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 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 orange dye (fd&c yellow # 6) used on the applicators is part of the design to serve a visual purpose of tinting the skin orange upon application to confirm the prepping of the patient¿s skin.The dye is an approved fda (federal drug agency) colorant and is an inactive ingredient to be used in foods, drugs, and cosmetics (fd&c).The dye (fd&c yellow # 6) is documented in the product labeling (inner carton, lidding, instruction for use (insert)) as an inactive ingredient.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 non-conformance was noted during the manufacturing of this lot.

Event Description

Material no.: 930815.Batch no.: 1097341.It was reported by the sales representative that the solution spilled/leaked within the package.It appears a few chloraprep packages with the solution spilled/leaked within in the package, but the prep stick has not been cracked.They are concerned whether or not this compromises the sterility/integrity of the prep stick.Per response email: it had appeared both prep sticks had not been cracked.I did not try shaking them or holding them up to a light.Both of the prep sticks in question were sent back with the shipping label provided by bd.

• 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 12388051
• MDR Text Key: 269381827
• Report Number: 3004932373-2021-00418
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 930815
• Device Lot Number: 1097341
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/13/2021
• Patient Sequence Number: 1