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

Catalog Number 260100

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

Patient Problem Insufficient Information (4580)

Event Date 12/07/2021

Event Type  Injury  

Event Description

It was reported that experienced more donor reactions recently.Ip chloraprep: i have a few medical staff that are inquiring what material the swab is made of for the 260100 chloraprep.We have experienced more donor reactions recently and are just wondering if the swab part is the reason.

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that experienced more donor reactions recently.Verbatim: ip chloraprep.I have a few medical staff that are inquiring what material the swab is made of for the 260100 chloraprep.We have experienced more donor reactions recently and are just wondering if the swab part is the reason.

Manufacturer Narrative

No additional information was provided by vitalant.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.

• Brand Name: CHLORAPREP SWABSTICK
• 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: 13043313
• MDR Text Key: 282496726
• Report Number: 3004932373-2021-00538
• Device Sequence Number: 1
• Product Code: KXF
• UDI-Device Identifier: 20354365400079
• UDI-Public: (01)20354365400079
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 260100
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other