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

Catalog Number 930480NSB

Device Problem Defective Device (2588)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

It was reported that the liquid in the prep is crystalized and cannot be used.Verbatim: i work for (b)(6) and we purchase your chloraprep app 1ml item code #930480nsb.I wanted to notify you that we have received a complaint from one of our customers.The complaint report stated the following: several nurses have recently reported an issue with the chloraprep swab inside of the iv start kits.The problem is that the liquid in the prep is crystalized and cannot be used.When it is popped, the liquid is in several pieces.A sample has not been received at this time.Have you received similar complaints for this issue? if you have additional insight or information that could be used for the investigation, please let me know.

Manufacturer Narrative

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

Manufacturer Narrative

A photo was provided for evaluation.Unfortunately, the failure mode could not be verified with the photo provided.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 the glass, it is possible to have an activated applicator and/or broken ampoule if the applicator undergoes excess handling.The production record review was completed for batch/lot 1054122 and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.Records reviewed indicate that the lot passed all the in-process inspections.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that the liquid in the prep is crystalized and cannot be used.Verbatim: per email 14-oct-2021 how many devices experienced the reported issue? 1 ea was reported are any of the affected devices or photos displaying the reported issue available? the photograph below is the only photograph that was provided.What is the address of the sample¿s location? a sample has not been received at this time.Was there any evidence of the ampoule broken prior to handling? could glass shards be seen when held up to a light or heard when shaken? it was noted in the complaint that when it is popped, the liquid is in several pieces.I can ask to see if there is additional information about glass shards/ampoule breaking prior to handling.I work for division 20 (centurion medical products) at medline and we purchase your chloraprep app 1ml item code #930480nsb.I wanted to notify you that we have received a complaint from one of our customers.The complaint report stated the following: several nurses have recently reported an issue with the chloraprep swab inside of the iv start kits.The problem is that the liquid in the prep is crystalized and cannot be used.When it is popped, the liquid is in several pieces.The photograph below was provided.However, a sample has not been received at this time.Have you received similar complaints for this issue? if you have additional insight or information that could be used for the investigation, please let me know.

• 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
• 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: 12771593
• MDR Text Key: 281585858
• Report Number: 3004932373-2021-00487
• 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: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 930480NSB
• Device Lot Number: 1054122
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other