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 Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Samples were provided for evaluation.Visual examination of the samples shows black specs on some of the samples.The specs were difficult to find due to there small dimensional size.As a result, the failure mode of black dots was verified on the samples analyzed.One possible root cause of the black specs is the printer of the packaging lidding.Production record review was completed for batches/lots 1054667, 1033703, 1055787 and no non-conformances were identified during the manufacturing of this lot.On june 30, 2021, the manufacturer updated current weekly preventive maintenance to include a thorough cleaning of all rollers (added idle rollers on the printer machine, mark andy equipment).No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported packaging issues.It was clarified that black dots appear and small spots of chloraprep leaking out prior to opening per response email: it is the same issue.They are having black dots appear and and small spots of chloraprep leaking out prior to opening.I have spoken to the customer many times about this per email: of the last 7 bx's of bd# 930815 we've received, we have had to remove 110 ea.From stock for the same packaging issues we were previously having.Breakdown by lot number below.Is bd going to look into this issue? can you issue restock for the damaged product?.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12240139
• MDR Text Key: 268147206
• Report Number: 3004932373-2021-00345
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 930815
• Device Lot Number: 1055787
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other