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

Catalog Number 930815NS

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

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

Event Description

It was reported that particulate was found.

Event Description

It was reported that particulate was found.

Manufacturer Narrative

Photographs were received for analysis.The photographs show black particles and a swabstick with a broken burnt end.The 1st particle is a large dark lint type particle.The failure mode of foreign matter was verified by photographs received from the customer.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 is the process which may create black specs and the raw material which was received from the supplier.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 10762510
• MDR Text Key: 213879091
• Report Number: 3004932373-2020-00119
• 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: 12/16/2020

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: 930815NS
• Device Lot Number: UNKNOWN, 9320861, 0072395
• 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: 12/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other