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

Catalog Number 930815

Device Problem Defective Device (2588)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Product was leaking.

Event Description

1 leakage of products, and 2 empty packaging.

Manufacturer Narrative

Emdr follow up: the failure mode of pre-activation was confirmed based on sample received for analysis showing orange stains on the original unopened package (lidding) and foam tip.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.No non-conformance was noted during the manufacturing of this lot 0289306.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11499844
• MDR Text Key: 242188692
• Report Number: 1423507-2021-00015
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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: 930815
• Device Lot Number: 0289306
• Date Manufacturer Received: 07/12/2021
• Patient Sequence Number: 1