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

Catalog Number 930480NSB

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

Patient Problem Rash (2033)

Event Date 06/25/2021

Event Type  Injury  

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 that patient developed a rash postoperatively after using the chloraprep.Per complaint details received: nurse inquiring if the bd chloraprep one step applicator has any other inactive ingredients then purified water.They have a patient that developed a rash postoperatively after using the chloraprep.Does not have a product code or lot number for the device used on the patient.States she does have a lot number for the type of chloraprep they use, lot# 0281517.Response: explained we were unable to find any information with the lot number provided.Informed the inactive ingredients for chloraprep one step applicator are as follows: fd&c green #3 dye (scrub-teal applicators only).

Manufacturer Narrative

No additional information was provided by the mayo clinic - scottsdale.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.Production batch history records for applicator pn 930480nsb lot number 0281517 was reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot.Records reviewed indicate that the lot passed all the in-process inspections.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.H3 other text : see narrative below.

Event Description

It was reported that patient developed a rash postoperatively after using the chloraprep.Per complaint details received: nurse inquiring if the bd chloraprep one step applicator has any other inactive ingredients then purifiedwater.They have a patient that developed a rash postoperatively after using the chloraprep.Does not havea product code or lot number for the device used on the patient.States she does have a lot number for thetype of chloraprep they use, lot# 0281517.Response explained we were unable to find any information with the lot number provided.Informed the inactiveingrdients for chloraprep one step applicator are as follows: fd&c green #3 dye (scrub-teal applicatorsonly).

• Brand Name: CHLORAPREP ONE STEP
• 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
• MDR Report Key: 12136031
• MDR Text Key: 260498956
• Report Number: 3004932373-2021-00316
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: 930480NSB
• Device Lot Number: 0281517
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other