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 930815

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/27/2021

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 that the prep leaked out and through the package.Per complaint details: i am reporting a chloraprep that was brought to my attention from a staff member.The prep leaked out an through the package.I filled out an arc on this item.

Manufacturer Narrative

No samples or photos are available for evaluation.As a result, bd was unable to verify the reported issue or determine a defined root cause.A production record review was completed and no non-conformance was noted during the manufacturing of this lot.No further actions is required at this time.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that the prep leaked out and through the package.Per customer response: i no longer have the item so i can¿t answer your question on that.Thanks for getting back to me, i had the item but do not have now, i apologize for not keeping the product in question.Per complaint details: i am reporting a chloraprep that was brought to my attention from a staff member.The prep leaked out an through the package.I filled out an arc on this item.

• 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: 11876776
• MDR Text Key: 268132871
• Report Number: 3004932373-2021-00253
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 930815
• Device Lot Number: 1013956
• Date Manufacturer Received: 08/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other