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

Catalog Number 930700NSB

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930700nsb.Batch no.: 0126294.It was reported debris found on the applicator.Per email: per sales rep: debris found on the chloraprep applicator.Picture attached- product.

Manufacturer Narrative

A photos has been provided for evaluation.Visual examination of the photo shows black foreign matter (much like black grease).As a result, bd was able to verify the reported issue.The lot number and the expiration date ink are not smeared or runaway.The numbers are clearly readable.The black spot below the numbers seems to be of a thicker viscosity than of the black ink more like a a thicker viscosity grease that might have occurred during post handling fabrication, assembly, or kitting.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported debris found on the applicator.Per sales rep: debris found on the chloraprep applicator.

Manufacturer Narrative

A photo has been provided for evaluation.Visual examination of the photo shows black foreign matter (much like black grease).As a result, bd was able to verify the reported issue.The black spot below the numbers seems to be of a thicker viscosity than of the black ink, such as grease.Bd¿s production equipment does not utilize grease or grease-like material therefore this foreign matter may have originated after leaving bd¿s control.A device history review was completed and no non-conformances we¿re identified during the manufacturing of this lot.In addition, this is the first reported issue that has been sent in for pn 930700nsb and lot.This is considered an isolated/rare occurrence.No further action is planned at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported debris found on the applicator.Per email: per sales rep: debris found on the chloraprep applicator.Picture attached- product.

• Brand Name: CHLORAPREP ONE STEP
• 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: 11152213
• MDR Text Key: 226793706
• Report Number: 3004932373-2020-00177
• Device Sequence Number: 1
• Product Code: KXG
• 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,Followup
• Report Date: 06/14/2021

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: 01/30/2023
• Device Catalogue Number: 930700NSB
• Device Lot Number: 0126294
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 03/08/2021
• Supplement Dates FDA Received: 03/08/2021; 06/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other