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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/15/2021

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).

Event Description

Material no.: unknown.Batch no.: unknown.It was reported microbiological flora on the incision site during use of chlorhexidine or povidone iodine solution.Per article: to determine the microbiologic flora after surgical skin preparation of the incision site using either chlorhexidine or povidone iodine antiseptic solution prior to cesarean section among obstetric patients.

• 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: 11388212
• MDR Text Key: 233966482
• Report Number: 3004932373-2021-00084
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• 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