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 Contamination /Decontamination Problem (2895)

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

Event Date 12/21/2021

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

They report that pieces with stains and foreign particles were found in the primary packaging.

Event Description

They report that pieces with stains and foreign particles were found in the primary packaging.

Manufacturer Narrative

Photos were provided for evaluation.Visual examination of the photos show both orange and black specs on various areas of packaged applicators.This verified the reported issue.The orange dye is not of foreign matter origin, but is an inactive ingredient inherit in the product.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.On july, 2021, the weekly preventive maintenance was updated to include a thorough cleaning of all rollers (added idle rollers on the printer machine, mark andy equipment).This printer is used to print the instructions on the lidding which the black specs may have originated from.These lots were manufactured from january 2020 to august 2021, almost a 2 year span, which may indicate a bolus reporting.The complaints should have been reported at time of occurrence/awareness.The most probable root cause for orange dye around the orange tinted pledget and black specs is the equipment, process and/or material variability inherent to the process and design.A production record review was completed for all reported batches/lots and no non-conformances were identified during the manufacturing of these lots.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

• 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: 13282884
• MDR Text Key: 295333817
• Report Number: 3004932373-2021-00559
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 261815
• Device Lot Number: 1063784
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other