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

Catalog Number 260480

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 01/13/2022

Event Type  malfunction  

Event Description

When using the 1ml chloraprep device, the content inside it is crystallized.

Manufacturer Narrative

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

Event Description

When using the 1ml chloraprep device, the content inside it is crystallized.

Manufacturer Narrative

Photos are available for evaluation.Visual examination of the photos show an activated 1 ml applicator which verifies an ampoule pre-activation occurred.The most probable root cause can be attributed to post marketing handling which can provided enough force/impact to activate and break the glass ampoule if the applicator undergoes excessive handling.A production record review was completed for batch/lot 0345886 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.

• 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: 13475134
• MDR Text Key: 296239854
• Report Number: 3004932373-2022-00036
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 20354365400062
• UDI-Public: (01)20354365400062
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 260480
• Device Lot Number: 0345886
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other