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 261815

Device Problem Defective Device (2588)

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

Event Date 01/17/2022

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

2 devices which do not present leakage stains, but in their inner part material is dry (crystalized).

Manufacturer Narrative

Photos were available for evaluation.Visual examination of the photos show excessive orange dry dye on package (web), foam tip and lidding are not tinted orange which does not indicate pre-activation but orange dye from pledget disperse inside package.The orange dots on the lidding do not infer leakage which may be interpreted as such due to color dispersion of the orange dye, but solution in contained within the glass ampoule.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 and is categorized as a cosmetic defect.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 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.As a result, bd verifies the reported issue of stain in foam.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 1250598 and no non-conformances were noted during the manufacturing of this lot.No further action is required.This failure will continue to be tracked and trended.See narrative below.

Event Description

2 devices which do not present leakage stains, but in their inner part material is dry (crystalized) additional information received on 26 jan 2022: ¿ when holding the products up to the light, is it possible to see glass fragments in the body of the applicators? a: no ¿ when shaking the products, is it possible to hear any glass rattling? a: no.

• 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: 13524198
• MDR Text Key: 296233176
• Report Number: 3004932373-2022-00047
• Device Sequence Number: 1
• Product Code: KXF
• UDI-Device Identifier: 50885403232709
• UDI-Public: (01)50885403232709
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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 Catalogue Number: 261815
• Device Lot Number: 1250598
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other