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

Catalog Number 273400A

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 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no: 273400a , batch no: 0308328.It was reported that by breaking the stick, the chlorhexidine remains in it and does not impregnate the foam.Verbatim: designation of the offending device chloraprep applicator 3ml (chlorhexidine gluconate + isopropyl alcohol).Reference (b)(4).Batch number, expiration dates and quantities of implicated devices.Total quantity of incriminated products: 1 lot 0308328 (expiration: 01/10/2023).

Event Description

Material no: 273400a batch no: 0308328 it was reported that by breaking the stick, the chlorhexidine remains in it and does not impregnate the foam.Verbatim: designation of the offending device chloraprep applicator 3ml (chlorhexidine gluconate + isopropyl alcohol) reference 273400a batch number, expiration dates and quantities of implicated devices total quantity of incriminated products: 1 lot 0308328 (expiration: 01/10/2023) description of the incident use of chloraprep for dialysis kt asepsis.By breaking the stick, the chlorhexidine remains in it and does not impregnate the foam.Incident date september 06, 2021 possible sending of the offending device: yes sending pictures of the offending device possible: no following this incident, we ask you a asset corresponding to the number of implicated devices.Reference of the report to be recalled in all correspondence:.

Manufacturer Narrative

The batch record for 273400a ln 0308328 was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.Based on no photograph or sample was received for analysis from the customer, the failure mode could not be confirmed.A possible root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate and break or fracture the glass ampoule.Due to the nature of glass it is possible to have an activated applicator and/or broken/fractured ampoule if the applicator undergoes excessive handling.This would result in a dry applicator or and applicator with not enough solution.Bd will continue to track and trend.

• 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: 12668259
• MDR Text Key: 277746895
• Report Number: 3004932373-2021-00477
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 273400A
• Device Lot Number: 0308328
• Date Manufacturer Received: 12/05/2021
• 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