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

Catalog Number 930815

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

Patient Problem Rash (2033)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by surgery center of (b)(6).(b)(6) 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.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.

Event Description

It was reported that the patients developed a rash around the surgical incision site after use of chloraprep.Per email: product catalog number: 930815.Product description: applicator 2% chg 70% isoprpnl 1 step apl 26ml orng hi-lt.Origin of the issue: patient safety.Detail: we have received reports of patients going home and then developing a rash (small red bumps that itch).The surgical incisions look normal, it is always the area around the incisions that the rash is located.The type of cases vary; three orthopaedic cases that involved the knee and one gynecology case in which the abdomen was prepped.Rash noted to be located in the surgical prep areas in every case.Lot # is not listed as we have various lot numbers for the prep here at the center and the specific lot number used in each case was not documented.We have started as of (b)(6) 2021 documenting the lot number for reference to any future issues.Prep sticks in hand and arthroscopic packs are the same prep sticks we have individually stocked on the shelf.Reported to vendor representative.Number of occurrences: 4.0.

• 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
• 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: 11628656
• MDR Text Key: 261314074
• Report Number: 3004932373-2021-00179
• 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: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other