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

Catalog Number 930500NSB

Device Problem Defective Device (2588)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material #930500nsb.Batch #1253363.It was reported that the chloraprep came in the pack dry.Verbatim: the chloraprep came in the pack dry.It wasn't deployed already, it was just dry.Received via : email (b)(6).External reference # (b)(4).Date of event- (b)(6) 2022.# of occurrences - 4.Email verbatim: complaint number: (b)(4).Created date 02-09-22.Event date (b)(6) 2022.Manufacturing site jrz.Product malfunction/failure mode dry.Product description summary: the chloraprep came in the pack dry.It wasn't deployed already, it was just dry.Complaint quantity 4.Sample available: yes.Presource component # 930500nsb~psprms.Mfg.Sku number: 930500nsb.Component name: applicator,prep,chloraprep,3ml,clear,ster sol,ns.Investigated component lot number: 1253363.Was there an injury: no.Was there a death : no.

Manufacturer Narrative

4464106based 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.No further action will be taken based on no adverse trend has been observed.Will continue to track & trend for this defect.

Event Description

Material #930500nsb.Batch #1253363.It was reported that the chloraprep came in the pack dry.Verbatium: the chloraprep came in the pack dry.It wasn't deployed already, it was just dry.Received via : (b)(4).External reference # (b)(4).Date of event- 08 february 2022.# of occurrences - 4.Email verbatim: complaint number: (b)(4).Created date: 02-09-22.Event date: 02-08-22.Manufacturing site: jrz.Product malfunction/failure mode: dry.Product description summary: the chloraprep came in the pack dry.It wasn't deployed already, it was just dry.Complaint quantity: 4.Sample available: yes.Presource component #: 930500nsb~psprms mfg.Sku number: 930500nsb.Component name: applicator,prep,chloraprep,3ml,clear,ster sol,ns.Investigated component lot number: 1253363.Was there an injury: no.Was there a death: no.

• 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: 13691933
• MDR Text Key: 286749427
• Report Number: 3004932373-2022-00068
• Device Sequence Number: 1
• Product Code: KXF
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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: Other
• Device Catalogue Number: 930500NSB
• Device Lot Number: 1253363
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/05/2022
• 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