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 Laceration(s) (1946)

Event Date 05/21/2021

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

It was reported by the facility representative that the patient developed arm scratches post cleaning with chloraprep wand.It has been reported that a donor developed scratches on arm post cleaning with a chloraprep wand: chloraprep lot no: 0315440 - exp: 10/23.The wand is not available for return as it has been disposed.

Manufacturer Narrative

A photo was available for evaluation.The photo shows the patient's arm with scratches.As a result, bd was able to verify the reported issue.Unfortunately, no further conclusions can be reached from the photo itself as to the root cause of the non-conformance.If 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.Current detection process controls include in-process inspections conducted by quality assurance.A production record review was completed for the batch/lot 0315440 and there we're no non-conformances related to the defect of "open seal" during the manufacturing of the lot.Without the actual sample, the root cause could not be defined at this time.No further actions are required.This failure mode will continue to be tracked and trended.

Event Description

It was reported by the facility representative that the patient developed arm scratches post cleaning with chloraprep wand.It has been reported that a donor developed scratches on arm post cleaning with a chloraprep wand :chloraprep lot no: 0315440 - exp: 10/23.The wand is not available for return as it has been disposed.

• 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
• MDR Report Key: 11917992
• MDR Text Key: 253749606
• Report Number: 3004932373-2021-00268
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 260407I
• Device Lot Number: 0315440
• Date Manufacturer Received: 07/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other