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

Catalog Number 930725NS

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 the particulate was found.

Event Description

It was reported that particulate was found.

Manufacturer Narrative

One photo was received by our quality team for evaluation.Upon visual inspection, a brownish fibrous particle was found inside 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 most probable root cause may be of cardboard origin caused by the process based on that the material is received from suppliers in cardboard boxes.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.H3 other text : see narrative below.

• Brand Name: CHLORAPREP ONE-STEP SCRUBTEAL
• 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: 10762737
• MDR Text Key: 213886077
• Report Number: 3004932373-2020-00118
• 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
• 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: 08/31/2022
• Device Catalogue Number: 930725NS
• Device Lot Number: 9283962
• 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