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

Catalog Number 260815C

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Skin Irritation (2076)

Event Date 10/27/2020

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 via a customer service inquiry that some patients may be experiencing skin irritation from chloraprep.

Manufacturer Narrative

No additional information was provided by the alberta health services (canada).Propharma did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.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 via a customer service inquiry that some patients may be experiencing skin irritation from chloraprep.

• 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10517757
• MDR Text Key: 206497694
• Report Number: 3004932373-2020-00042
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 260815C
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other