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

Catalog Number 260407I

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

Patient Problem Abrasion (1689)

Event Date 12/10/2021

Event Type  Injury  

Event Description

State and country not provided at time of entry chloraprep ¿ qi28172.Material #qi28172 - batch #1151908.Email verbatim: ¿hello, i am writing from nhs blood and transplant.We have had an incident raised (qi28172) when, during arm cleaning for blood donation, the chloraprep wand left multiple small scratches on donor's arm.The donor experienced no stinging and was comfortable.Lot no ¿ 1151908, exp 05/24.Photograph below.We often have a form sent over to us to complete following these reports, however, we have no further information to provide regarding this incident." state and country not provided at time of entry.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

State and country not provided at time of entry chloraprep ¿ qi28172.Material #qi28172 - batch #1151908.Email verbatim: ¿hello, i am writing from nhs blood and transplant.We have had an incident raised qi28172 when, during arm cleaning for blood donation, the chloraprep wand left multiple small scratches on donor's arm.The donor experienced no stinging and was comfortable.Lot no ¿ 1151908, exp 05/24.Photograph below.We often have a form sent over to us to complete following these reports, however, we have no further information to provide regarding this incident." state and country not provided at time of entry.

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photos shows scratches on the patient's arm.This verifies the reported issue.Unfortunately, without the actual sample, a definitive root cause could not be determined at this time.A production record review was completed for batch/lot 1151908 and there were no non-conformances related to the defect of 'open seal' during the manufacturing of this lot.In the event that the foam is not welded correctly onto the body it is possible there is an open seal that may result in potential cuts and scratches.No further actions are required.This failure will continue to be tracked and trended.

Event Description

It was reported that during arm cleaning for blood donation, the chloraprep wand left multiple small scratches on donor's arm.Email verbatim: ".I am writing from nhs blood and transplant we have had an incident raised (b)(4) when, during arm cleaning for blood donation, the chloraprep wand left multiple small scratches on donor's arm.The donor experienced no stinging and was comfortable.Lot no ¿ 1151908, exp 05/24.Photograph below.We often have a form sent over to us to complete following these reports, however, we have no further information to provide regarding this incident." state and country not provided at time of entry.State and country not provided at time of entry.Chloraprep ¿ (b)(4).

• Brand Name: CHLORAPREP ONE STEP
• 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: 13060251
• MDR Text Key: 285537858
• Report Number: 3004932373-2021-00539
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 27613203022112
• UDI-Public: (01)27613203022112
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260407I
• Device Lot Number: 1151908
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other