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 273715

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/09/2021

Event Type  malfunction  

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 by the user facility that product is leaking.Illisisble writing fuite de solution.(product leaking).

Manufacturer Narrative

The failure mode of leakage (pre-activation) was verified based on photograph received for analysis showing the orange tinted foam tip and lidding.Ampoules are made from onion tubing skin borosilicate type i glass, which are design to break when pressure is applied to activate applicator 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 handing.Production record review was completed for batch/lot 0322656 and no non-conformance was noted during the manufacturing of this lot.No further actions are required at this time.This failure will continue to be tracked and trended.H3 other text: see narrative below.

Event Description

It was reported by the user facility that product is leaking.Illisisble writing fuite de solution.(product leaking).

• 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
• MDR Report Key: 12278693
• MDR Text Key: 265159253
• Report Number: 3004932373-2021-00357
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 273715
• Device Lot Number: 0322656
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other