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

Catalog Number 930700NS

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Pr 1879084 initial mdr.A follow up will be submitted if additional information becomes available.Patient problem code: 2692, device problem code: 2895.Na.

Event Description

It was reported that particulate was found.

Manufacturer Narrative

One photo was received by our quality team for evaluation.Upon visual inspection, it was observed that there were orange particles inside of the package; therefore, the incident could be verified.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.Based on the investigation, the probable root cause could be from the manufacturing process.On 10.5ml applicators, particles may be created on rare occasions during the ultrasonic welding of the foam tip onto the applicator body which makes the foam brittle and pieces flake off.This failure mode is of foam origin not of foreign origin and it may be created as a byproduct of the ultrasonic welding process caused by the equipment.However, without a physical sample a full investigation could not be performed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that particulate was found.

• Brand Name: CHLORAPREP ONE-STEP
• 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: 10762738
• MDR Text Key: 213881083
• Report Number: 3004932373-2020-00116
• 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: 12/30/2020

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 930700NS
• Device Lot Number: 9313761
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 12/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other