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 930715NSB

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/18/2021

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 available for evaluation.Visual examination of the samples show 2 applicators with orange tinted foam tips.As a result, bd was able to verify the reported issue of pre-activation.The most probable root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate and break the glass ampoule.The master shipper has an impact mark which confirms an impact compression force occurred resulting in pre-activated applicators.Production record review was completed for batch/lot 1086029 and no non-conformances were identified during the manufacturing of this lot.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported by the facility representative that the applicators were leaking prior to use.Per email: we just received a rejection for the below item: busse# 8410c (bd# 930715nsb )  rejection# r037721.From 1 of the cases under po (b)(4), some pieces were found to be leaking.We would like to get a replacement case for this case that we can't use.Please confirm to send a replacement po for 1 case.Also, please let me know if you would like us to scrap or return this case that has the leaking pieces in it? and if return, please provide return instructions.

• 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: 11947516
• MDR Text Key: 267867686
• Report Number: 3004932373-2021-00275
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 930715NSB
• Device Lot Number: 1086029
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other