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

Catalog Number 930725NS

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the distributor that there was foreign particulate and dirty.

Manufacturer Narrative

The batch record for pn 930725ns ln 0319648 was reviewed and there are no defects reported related to "foreign material" during routine in-process inspections during the packaging of the lot.Bd was unable to perform a thorough investigation as no sample ,was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no.: 930725ns.Batch no.: 0319648.It was reported by the distributor that there was foreign particulate and dirty.Per report: foreign particle and dirty.

• 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 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 12337456
• MDR Text Key: 267096123
• Report Number: 3004932373-2021-00392
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• 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: 09/22/2021

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: 10/31/2023
• Device Catalogue Number: 930725NS
• Device Lot Number: 0319648
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/24/2021
• Patient Sequence Number: 1