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

Catalog Number 930825

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/10/2021

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

Material no.: 930825.Batch no.: unknown.It was reported the patient had a rash breakout reaction.Per complaint form: met dr.[omitted] in (b)(6) before her laparoscopic hysterectomy case.Dr.{omitted] mentioned that a few weeks ago she had two separate patients that had bad reactions to chloraprep after being prepped at (b)(6) regional.One patient had the chloraprep 26ml orange tint administered, and the second patient had the chloraprep 26ml teal tint administered and both patients had similar rash breakout reactions.Dr.[omitted] asked me if the formulation had been changed, and i said that the only difference is that the product is now deemed sterile.Dr.[omitted] wanted me to pass this information up the chain-of-command.Two separate patients needed to be administered steroid medications for the bad rash.One patient had a bad abdominal rash, and a separate patient had an abdominal rash and rash on her back where chloraprep had been prepped for an epidural.I asked dr.If the proper 3 minute dry-time was followed, and she said it had been followed properly.Not sure if patients had chg allergies.

• Brand Name: CHLORAPREP ONE STEP SCRUB TEAL
• 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
• 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: 11558910
• MDR Text Key: 241952742
• Report Number: 3004932373-2021-00148
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2021

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 Catalogue Number: 930825
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other