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

Catalog Number 930480NSB

Device Problem Defective Device (2588)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930480nsb , batch no.: 0253553.It was reported there is no fluid in the applicator.Per email: medical action industries recently received a complaint for the below issue involving your chloraprep# 930480nsb, lot# 0253553, that was placed in our kit.The quantity affected is approximately 1 ea.There is no photo or sample for this complaint.This notification is for awareness only.We do not require a response from bd.Complaint issue: chloraprep did not have any juice (fluid) in it.

Manufacturer Narrative

No photograph or sample was received: therefore the failure mode could not be confirmed nor the corrective action be determined.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.No further action will be taken based on this failure modes is mostly related t transportation once the product leaves the distribution center.Production batch history records for applicator pn 930480nsb lot number 0253553 were reviewed and no non-conformities, failures, deviations, qns or rework activities occurred during the manufacturing of this lot, similar to the reported issue, or that could have contributed to the reported failure mode.Records reviewed indicate that the lot passed all the in-process inspections.H3 other text : see narrative section.

Event Description

Material no.: 930480nsb batch no.: 0253553.It was reported there is no fluid in the applicator.Per email: medical action industries recently received a complaint for the below issue involving your chloraprep# 930480nsb, lot# 0253553, that was placed in our kit.The quantity affected is approximately 1 ea.There is no photo or sample for this complaint.This notification is for awareness only.We do not require a response from bd.Complaint issue: chloraprep did not have any juice (fluid) in it.

• 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: 11802524
• MDR Text Key: 268132745
• Report Number: 3004932373-2021-00238
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 08/31/2023
• Device Catalogue Number: 930480NSB
• Device Lot Number: 0253553
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other