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

Catalog Number UNKNOWN

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Irritation (1941)

Event Date 02/19/2021

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 the customer or author of the article - for lit review).Primevigilance 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.

Event Description

It was reported that the chloraprep caused the patient to be itchy.Per email: case number:(b)(4).Question: does chloraprep need to be removed post surgery? nurse states she was never trained to do this and was actually trained not to remove it.She states after the patient was moved to the floor post c-section (case performed (b)(6) 2021) she complained of itching and wanted to know why it was not cleaned off after the case was completed.Response: confirmed it is not necessary to remove the chloraprep.Emailed report of itching to product complaints.The product and lot number were not available anymore and she is unsure exactly when the patient made the report of itching.She was approached by another nurse who it was reported it.

• Brand Name: UNKNOWN CHLORAPREP
• 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: 11388347
• MDR Text Key: 243844818
• Report Number: 3004932373-2021-00087
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/25/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other