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

Catalog Number 930815NS

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

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

Event Date 01/27/2021

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 the device was dirty/stained.

Manufacturer Narrative

Production batch history records for applicator pn 930815 lot number 0260171 were reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.Records reviewed indicate that the lot passed all the in-process inspections.Failure mode was not confirmed for this complaint due to no pictures or samples sent for analysis.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.H3 other text : see narrative below.

Event Description

Material no.: 930815ns, batch no.: 0260171.It was reported by the distributor that the device was dirty/stained.Per report: dirty/stained.

• Brand Name: CHLORAPREP ONE-STEP HILITE ORANGE
• 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: 12337335
• MDR Text Key: 267096266
• Report Number: 3004932373-2021-00390
• 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: 08/31/2023
• Device Catalogue Number: 930815NS
• Device Lot Number: 0260171
• 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