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

Catalog Number 930815

Device Problem Defective Device (2588)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930815.Batch no.: 136710.It was reported by the distributor that the applicator has very little liquid.

Manufacturer Narrative

Photograph received for analysis shows a conforming applicator inside the original unopened package.From the photograph the failure mode of solution not enough could not be confirmed.The lot number reported is not a true lot number and the batch record could not be performed.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.: 930815, batch no.: 136710.It was reported by the distributor that the applicator has very little liquid.Per email: we were notified of a complaint from a customer stating chloraprep has very little liquid.Please see the below details regarding the reported issue.If it is indicated that a sample is available, please provide shipping instructions within 30 days or the sample will be disposed of.Medline complaint #: (b)(4).Defect description: chloraprep has very little liquid.Medline part #: 136710.Product description: chloraprep app 26ml orange.Vendor part #: 930815.Lot #: 0.Po#: unknown.Sample received: no.Response needed: no.

• Brand Name: CHLORAPREP ONE STEP HI LITE ORANGE
• 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: 12055431
• MDR Text Key: 268262728
• Report Number: 3004932373-2021-00302
• Device Sequence Number: 1
• Product Code: KXG
• 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: 08/31/2021

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 Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 08/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other