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

Catalog Number 930500NSB

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930500nsb, batch no.: unknown.It was reported by the distributor that the sponges of the chloraprep applicators are not becoming wet once activated.Per email: there was some fluid in the ampoules.The fluid that wasn¿t dry did not soak the sponge.I have asked staff to save covers from any further impacted product they find.I will share it with you when i have it.Per email: complaint for the below issue involving your chloraprep# 930500nsb, placed in our kits.We are currently working with the customer to obtain lot numbers and if any samples are available.As soon as i receive any additional information, i will forward immediately.The customer is claiming 28 ea.Per the complaint report, the event date is (b)(6) 2021.The customer's contact information is noted below in case you have a chloraprep representative in that region who may want to visit in regard to this issue.Please forward your investigation results as soon as possible.Complaint issue: per the customer, "we have noticed that the chloraprep 3 ml in our port access kits are not working properly.We have accessed about 116 ports this week, and there were 28 port kits that the chloraprep did not work.When the nurses squeeze the handle to activate the solution, it does not come down to the sponge to wet it.The nurses have had to doff their sterile gloves, grab another chloraprep and drop it into their sterile field, and then don a second set of sterile gloves.This has resulted in delays and is time-consuming.Since there were at least 28 kits with the choraprep issue, they did not have time to enter all of these rl6s so they informed me of this instead.".

• 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: 11936599
• MDR Text Key: 268134254
• Report Number: 3004932373-2021-00273
• Device Sequence Number: 1
• Product Code: KXF
• 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: distributor,other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 930500NSB
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other