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 05/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Material no.: 260407i , batch no.: 0316575.It was reported by the facility representative that following arm cleaning the donor developed scratches on their arm.Per email: we have just logged an incident regarding relating chloraprep wand batch no: 0316575 - exp 10/2025.Following arm cleaning the donor developed scratches on their arm in the area the chloraprep was used.I can confirm that the chloraprep wand has been discarded; there are no images of the donors arm.

Event Description

Material no.: 260407i.Batch no.: 0316575.It was reported by the facility representative that following arm cleaning the donor developed scratches on their arm.Per email: we have just logged an incident regarding relating chloraprep wand batch no: 0316575 - exp 10/2025.Following arm cleaning the donor developed scratches on their arm in the area the chloraprep was used.I can confirm that the chloraprep wand has been discarded; there are no images of the donors arm.

Manufacturer Narrative

Batch record for pn 260407i ln 0316575 was reviewed and there were no non-conformances related to the defect of "open seal" during the manufacturing of the lot.Without the actual sample for analysis the root cause could not be confirmed.We will continue to track and trend for this defect follow up emdr (b)(4).H3 other text: see narrative.

• 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: 11844549
• MDR Text Key: 265977465
• Report Number: 3004932373-2021-00243
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 260407I
• Device Lot Number: 0316575
• Date Manufacturer Received: 08/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR