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

Catalog Number 260599NSB

Device Problem Illegible Information (4050)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that a label was illegible.

Manufacturer Narrative

No samples or photos were provided for evaluation.Unfortunately,the failure mode could not be verified and a root cause could not be defined.Product record review could not be completed as the lot information was unavailable.No previous complaint from the same product code related to complaint code "other - label content illegible" have been received from august 2018 to august 2020.No adverse trend observed, defect is within control limits.No further actions will be taken at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that a label was illegible.

• 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: 10463795
• MDR Text Key: 215379665
• Report Number: 3004932373-2020-00011
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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: Other
• Device Catalogue Number: 260599NSB
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 11/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other