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 273815

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that chloraprep leaks.Verbatim per bing translator: as part of the clean 2 test, the service rejected several batches of chloraprep that had suffered leaks (sealed pooch, interior fully colored red) 3 of lot 0293813 exp 10/23, 2 of lot 0114655 exp 04/23 1 of lot 9054707 exp 01/22 (as a reminder there had been a precedent with lot 7345827 exp 11/20 1 of this lot had the same problem).

Event Description

It was reported that chloraprep leaks.Verbatim per bing translator: as part of the clean 2 test, the service rejected several batches of chloraprep that had suffered leaks (sealed pooch, interior fully colored red) 3 of lot 0293813 exp 10/23, 2 of lot 0114655 exp 04/23 1 of lot 9054707 exp 01/22 (as a reminder there had been a precedent with lot 7345827 exp 11/20 1 of this lot had the same problem).

Manufacturer Narrative

Photos were provided for evaluation.Visual examination shows applicators with the foam tip and lidding tinted orange indicating pre-activation occurred.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.Due to the nature of glass, it is possible to have an activated applicator and/or broken ampoule if the applicator undergoes excessive handing.A production record review was completed for batches/lots 0293813, 0114655, 9054707 and 7345827 and no non-conformance was noted during the manufacturing of these lots.No further actions are required.This failure will continue to be tracked and trended.

• 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: 12644478
• MDR Text Key: 276913645
• Report Number: 3004932373-2021-00468
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Catalogue Number: 273815
• Device Lot Number: 7345827
• Date Manufacturer Received: 10/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other