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

Catalog Number 930815

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that chloraprep leaking in pack.Verbatim: received via: email.External reference # (b)(4).# of occurrences -1.

Event Description

It was reported that chloraprep leaking in pack verbatim: received via : email.External reference # (b)(4).# of occurrences -1.Reported issue: chloraprep leaking in pack.

Manufacturer Narrative

Photos were available for evaluation.Visual examination of the photos show the foam tip and lidding tinted orange in a kit which verifies the failure mode of pre-activation.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 handing.A production record review was completed for batch/lot 1191738 and no non conformances were identified during the manufacturing of this lot.No further actions are required at this time.This failure will continue to be tracked and trended.

• Brand Name: CHLORAPREP ONE STEP HI-LITE ORANGE
• 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: 13757777
• MDR Text Key: 287115821
• Report Number: 3004932373-2022-00071
• Device Sequence Number: 1
• Product Code: KXG
• 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: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 930815
• Device Lot Number: 1191738
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other