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

Catalog Number 312480

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

When opening chloraprep the product is crystallized.

Manufacturer Narrative

Photos were provided for evaluation.Visual examination of the photos was completed and it was deemed the defect was a broken ampoule and the glass shards was mistaken for crystallization.The ampoule is made of glass and is designed to break at a relatively low break force.When pressure is applied to the wings by a pinching force with the fingers, this activates the applicator; breaking the glass ampoule and releasing the chloraprep solution onto the foam tip.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.Ampoules are made from glass tubing onion skin borosilicate type i which is designed to break when pressure is applied to activate applicator.Production record review was completed for batch/lot 0174129 a no non-conformances were documented during the manufacturing of this lot.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

When opening chloraprep the product is crystallized.

• 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: 11326636
• MDR Text Key: 243888645
• Report Number: 3004932373-2021-00051
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 312480
• Device Lot Number: 0174129
• Date Manufacturer Received: 04/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other