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

Catalog Number 930715

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ifu is not inside the pouch.

Manufacturer Narrative

Two photos were received by our quality team for evaluation.The photo showed one applicator with the insert inside the package and another applicator without the insert.The lidding seems to be different but could not determined if the product codes were different or an older version of the product was being compared.Product code 930715 does not include an insert inside the pouch (original unopened package), but one insert is included inside the inner carton.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.A total of ten (10) retain samples were inspected with 1 insert was inside the inner carton and no inserts were observed inside the original unopened package (pouch).A change control was performed on june 2020 on the insert instruction.The lot reported was manufactured after june 2020 so it is in specification.No issue identified; therefore, a root cause is not determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

Event Description

It was reported that the ifu is not inside the pouch.

• 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 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11169762
• MDR Text Key: 226784009
• Report Number: 3004932373-2020-00181
• Device Sequence Number: 1
• Product Code: KXG
• 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
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 930715
• Device Lot Number: 0254377
• Date Manufacturer Received: 02/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other