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

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by the (b)(6) hospital.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.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 by the sales representative that the patient experienced a hair follicle being infected [folliculitis] after use of chloraprep.Per final cioms, redness [redness], rash down the arms [rash], hair follicle being infected [folliculitis].Have either of you heard of recent issues with chlorapreps? [nurse] brought to my attention 2 shoulder scopes that dr completed on (b)(6) 2021; both had complaints redness, rash down their arms.(b)(6) saw them in the office and she describes it as "hair follicles being infected; almost like a skin cellulitis; bumpy red rash; one lady's skin was peeling off her neck".The incision sites look good, but the chloraprep is being washed off after the case around the incision before dressed.I questioned if it could possibly be the prep, but then these are the first 2 i have heard like this.During an ortho touch base call this morning, [nurse] told me that she reached out to a nurse at one and she communicated that they have been seeing issues as well, but with a different surgeon's shoulder scope patients.I know it sounds bizarre, but could it potentially be the chlorapreps? have you heard of these issues at any other facility? thanks for the notification.I have copied the chloraprep rep with this email, so we do need to be careful with hipaa info going forward.I personally, have not had anyone tell me what you are saying below.Some things to consider is the clipping¿was it the same person clipping on the patients who experienced the rash? i am assuming people are using the clipper and not a razor, but it would be good to ensure the clipping is done per the mfg instructions.Attached is the inservice poster.I also would like to know the lot number if it is possible.Was it the same size and lot number prep? so any other details would be nice to know.It is interesting it is scope patients.(b)(6), any other thoughts or info you need? over the past couple of months, we've done education with staff regarding clipper prepping.We always clipper prep; not razor.Interesting enough this is what i found with our 3 shoulder scope patients.1 [patient] with a rash whose skin was visibly peeling on her neck didn't have a clipper prep.1 [patient] with a rash had a dry clipper prep.1 [patient] without any complaints post op had a wet clipper prep.

• Brand Name: CHLORAPREP UNKNOWN
• 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: 11996349
• MDR Text Key: 256151720
• Report Number: 3004932373-2021-00285
• Device Sequence Number: 1
• Product Code: KXF
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other