MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP TEAL; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 930825

Device Problem Defective Device (2588)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Material no.: 930825.Batch no.: unknown.It was reported dry chloraprep sticks in side the package.Per email: we were notified of a complaint from a customer stating dry chloraprep sticks in the pack.Please see the below details regarding the reported issue.If it is indicated that a sample is available, please provide shipping instructions within 30 days or the sample will be disposed of.

• Brand Name: CHLORAPREP ONE STEP TEAL
• 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: 11806547
• MDR Text Key: 266482729
• Report Number: 3004932373-2021-00239
• 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: 05/03/2021

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 Catalogue Number: 930825
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other