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

Catalog Number 270400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material no.: 270400.Batch no.: 0274685.It was reported the patient experienced dryness and redness on skin using chloraprep.This initial report is being reported by lpch on behalf of the patient's husband.A [omitted] patient with [omitted] started using chlorprep alongside her medication for pulmonary hypertension in 2010.Batch number and expiry date- 0274685 (30/09/23).On (b)(6) 2021 the patient's husband reported the patient is experiencing dryness and redness on her skin where she applies chloroprep.At the time of the report the outcome of the event was unknown.The patient's husband considered the event as "reported causality" to chloroprep.No medical history available.The patient takes veletri.No other medications taken by the patient are known.No further information was provided.The patient was taking chloroprep for: pulmonary hypertension.

Event Description

Material no.: 270400 batch no.: 0274685 it was reported the patient experienced dryness and redness on skin using chloraprep.This initial report is being reported by lpch on behalf of the patient's husband.A [omitted] patient with [omitted] started using chlorprep alongside her medication for pulmonary hypertension in 2010.Batch number and expiry date- 0274685 (30/09/23).On (b)(6) 2021 the patient's husband reported the patient is experiencing dryness and redness on her skin where she applies chloroprep.At the time of the report the outcome of the event was unknown.The patient's husband considered the event as "reported causality" to chloroprep.No medical history available.The patient takes veletri.No other medications taken by the patient are known.The patient was taking chloroprep for: pulmonary hypertension..

Manufacturer Narrative

Chloraprep (b)(6) lot number 0263751 was reviewed and no non-conformities, failures, deviations, or rework activities occurred during the formulation of this lot.No photograph or sample was received for analysis; therefore, the failure mode could not be confirmed, nor could the root cause be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Follow up emdr (b)(6).

• Brand Name: CHLORAPREP ONE STEP
• 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: 11558892
• MDR Text Key: 257139047
• Report Number: 3004932373-2021-00144
• Device Sequence Number: 1
• Product Code: KXF
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 270400
• Device Lot Number: 0274685
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR