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

Catalog Number 312480

Device Problem Defective Device (2588)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When trying to use the chloraprep, it was noticed that its content is crystallized.

Event Description

When trying to use the chloraprep, it was noticed that its content is crystallized.

Manufacturer Narrative

Failure mode was not confirmed due to no sample received.The most probable root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate and break the glass ampoule.Due to the nature of glass, it is possible to have an activated applicator and/or broken ampoule if the applicator undergoes excessive handling.

• 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: 11947784
• MDR Text Key: 268134569
• Report Number: 3004932373-2021-00276
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 312480
• Device Lot Number: 0286480
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other