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

Catalog Number 260400 MX

Device Problem Defective Device (2588)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect ¿ clinical code: (b)(4).Imdrf annex a code medical device problem code: (b)(4).

Event Description

The product was opened to perform a curing, and at the moment of pressing the wings the nurse noticed it does not contain the antiseptic.

Manufacturer Narrative

Photo was provided for evaluation.Visual examination of the photo does not provide enough information to verify the reported issue or determine a definitive root cause at this time.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.A production record review was completed for batch/lot 0311455 and there were no non-conformances related to the reported defect of ¿broken ampoule or missing ampoule¿ during the manufacturing of the lot.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

The product was opened to perform a curing, and at the moment of pressing the wings the nurse noticed it does not contain the antiseptic.Additional information received: ¿ how many units of the product presented the reported deviation? r? one ¿ has there been any harm to the patient due to the delay in medication administration times? a: no, just delay in the procedure.¿ was there a need for medical intervention due to what happened (imaging tests, surgery, administration of other medications, etc.)? a: no ¿ could you send photos and/or videos of the product and/or packaging, so that it is possible to observe the notified deviation? a: photo attached.¿ are there orange spots on the packaging? a: no.¿ when holding the product up to the light, is it possible to see glass fragments in the applicator body? a: yes ¿ when shaking the product, is it possible to hear any glass rattling? a: yes.

• 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: 13472429
• MDR Text Key: 296235660
• Report Number: 3004932373-2022-00035
• Device Sequence Number: 1
• Product Code: KXF
• UDI-Device Identifier: 20885403427111
• UDI-Public: (01)20885403427111
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 260400 MX
• Device Lot Number: 0311455
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 YR
• Patient Sex: Male
• Patient Weight: 7 KG