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 260815

Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

At the moment of labeling, it was detected 1 unit damaged ((b)(6) 2021): it's confirmed that when evaluating the device with defect, it is determined that no rattling of glass can be heard, and when holding the applicator to the light no glass shards are observed.It's observed only the leakage, that has affected the package.

Manufacturer Narrative

The failure mode was confirmed based on photographs received for analysis showing orange stains on the foam tip, and on the applicator end.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.

Event Description

At the moment of labeling, it was detected 1 unit damaged (a.Alcaraz, 25.Mar.2021): it's confirmed that when evaluating the device with defect, it is determined that no rattling of glass can be heard, and when holding the applicator to the light no glass shards are observed.It's observed only the leakage, that has affected the package.

• 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: 11683723
• MDR Text Key: 268122485
• Report Number: 3004932373-2021-00201
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 260815
• Device Lot Number: 0283167
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Patient Sequence Number: 1