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

Catalog Number 312400

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Empty material (no solution).

Manufacturer Narrative

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

Manufacturer Narrative

Based on no photograph or sample was received for analysis from the customer, the failure mode could not be confirmed.The ampoule is made of glass and is designed to break at a relatively low break force.When pressure is applied to the wings by a pinching force with the fingers, this activates the applicator; breaking the glass ampoule and releasing the chloraprep solution onto the foam tip.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 handling.Without the actual sample a root cause can't be determined.The batch record for pn 312400 ln 8057519 was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.No further action will be taken based on no adverse trend has been observed.Will continue to track & trend for this defect.H3 other text : see narrative below.

Event Description

Empty material (no solution).Customer sent to us the information below.What is the batch of product? the number 807519 is invalid (not found in our database) sorry for the misunderstanding, following batch: 8057519.

• 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: 12914403
• MDR Text Key: 286136469
• Report Number: 3004932373-2021-00512
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 30382903124009
• UDI-Public: (01)30382903124009
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 312400
• Device Lot Number: 8057519
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other