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

Catalog Number 930500NSB

Device Problems Premature Activation (1484); Defective Component (2292)

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported chloraprep applicator had no liquid.

Manufacturer Narrative

Samples were received by our quality team for evaluation.Based on the samples, the incident of pre-activation could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, 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.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

Event Description

It was reported chloraprep applicator had no liquid.

• 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: 11435108
• MDR Text Key: 267933882
• Report Number: 3004932373-2021-00097
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 930500NSB
• Device Lot Number: 0189104
• Date Manufacturer Received: 06/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other