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

Catalog Number 930599NSB

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 12/30/2020

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 there was a piece of plastic or foreign object on the sponge that caused a scrape to the patient's arm.Per email: we recently received a medwatch from the fda for a chloraprep injury involving your chloraprep item# 930599nsb, lot# 0230977, of 1 each/incident.Date of event is (b)(6) 2020.Complaint issue noted below.Per the customer, there was no medical treatment documented and she has the actual sample involved for your examination.Complaint issue: when starting an iv on this patient, scrubbing with the sponge, unknown if there was a piece of plastic or something on the sponge, but it made scrape marks on his arm.

Manufacturer Narrative

A sample was received for evaluation.Visual examination of this sample and no sharp body was found on the sample returned.As a result, bd was unable to verify the reported issue or define a root cause at this time.Production record review was completed for batch/lot 0230977 and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported there was a piece of plastic or foreign object on the sponge that caused a scrape to the patient's arm.Per email: we recently received a medwatch from the fda for a chloraprep injury involving your chloraprep item# 930599nsb, lot# 0230977, of 1 each/incident.Date of event is (b)(6) 2020.Complaint issue noted below.Per the customer, there was no medical treatment documented and she has the actual sample involved for your examination.Please acknowledge receipt of this notification.We ask that you respond directly to the customer (noted below) for the sample and your final investigation results (cc me).Customer contact information: [omitted].Complaint issue: when starting an iv on this patient, scrubbing with the sponge, unknown if there was a piece of plastic or something on the sponge, but it made scrape marks on his arm.

• Brand Name: CHLORAPREP ONE-STEP
• 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
• MDR Report Key: 11339685
• MDR Text Key: 240736048
• Report Number: 3004932373-2021-00057
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• 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: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 930599NSB
• Device Lot Number: 0230977
• Date Manufacturer Received: 07/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR