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 260715

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/28/2021

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

Sales representative reports: "supplies arrive from the plant to our client code 260715, one activated and the other with a foreign matter inside".

Event Description

Sales representative reports: "supplies arrive from the plant to our client code 260715, one activated and the other with a foreign matter inside".

Manufacturer Narrative

Photo was provided for evaluation.Visual examination of the photo shows a foreign substance on the foam of the applicator.This verified the reported issue.A review of the clean and use logbook for the machine shows that the machine was cleaned prior to lot start-up.A definitive root cause can not be identified without an actual sample to evaluate.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the packaging of the product.A production record review was completed for batch/lot 1070740 and no non-conformities, failures, deviations, 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.No further actions are required.This failure will continue to be tracked and trended.

• 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: 12360507
• MDR Text Key: 267903105
• Report Number: 3004932373-2021-00413
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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: 02/29/2024
• Device Catalogue Number: 260715
• Device Lot Number: 1070740
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 09/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other