MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP FREPP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 260599NSB

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 260599nsb.Batch no.: 0144457.It was reported by the facility representative that the lot number of the component does not match the box lot number.Per ncmr report: lot number of the component does not match the box lot number.

Event Description

Material no.: 260599nsb, batch no.: 0144457.It was reported by the facility representative that the lot number of the component does not match the box lot number.Per ncmr report: lot number of the component does not match the box lot number.

Manufacturer Narrative

Follow up emdr pr 2858660.We investigated and determined the root cause to be attributable to inadequate line clearance.A capa has been opened to determine the appropriate corrective action(s).Target date for implementation is (b)(6) 2021.Batch record for pn 260599nsb ln 0144457 was reviewed and there were no non-conformances related to the reported defect of mixed product during the manufacturing of the lot.Return samples received were in a plastic ziploc bag and were not on the inner carton.Plastic applicators received were indeed printed with the lot number 0149140 expiration date 04/23.

• Brand Name: CHLORAPREP ONE STEP FREPP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11877988
• MDR Text Key: 252445483
• Report Number: 3004932373-2021-00256
• 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: 08/19/2021

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 260599NSB
• Device Lot Number: 0144457
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other