MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI LITE ORANGE; 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 12/02/2021

Event Type  malfunction  

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: 930500nsb batch no: 1088484, 1081844, and 1044870.It was reported that the chloraprep applicator used for cleaning is dried.Verbatim: i work for medline at division 20 (centurion medical) and we purchase your 3 ml chloraprep applicator (component 930500nsb).I wanted to notify you that we have received a complaint from one of our customers.The complaint report stated the following: the chloraprep applicator used for cleaning is dried.The component information is the following: centurion material no.: 136719.Po nos.: 6000005444, 6000005133, and 6000004438.Vendor material no.: 930500nsb.Vendor lots nos.: 1088484, 1081844, 1and 044870.Unfortunately, neither a sample or picture could be provided by the customer.Could you find out if there have been similar complaints reported and evaluate retains/production records? if you have additional insight or information that could be used for the investigation, please let me know.

• Brand Name: CHLORAPREP ONE STEP HI LITE ORANGE
• 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 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12971145
• MDR Text Key: 289742496
• Report Number: 3004932373-2021-00531
• Device Sequence Number: 1
• Product Code: KXG
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 930500NSB
• Device Lot Number: 1081844
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other