MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP UNKNOWN; 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 08/26/2021

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

It was reported by the health professional that the applicator leaked out of the bottom.Per email: i've been working in surgery for over 14 years and have been using chloraprep extensively.As much as chloraprep is used in surgery all over, i would believe that bd could design an applicator that doesn't leak out of the bottom of it every time it is used.Are your teams working on improving the design of the applicator so it doesn't leak?.

Manufacturer Narrative

A video was received for analysis showing solution leakage on the end cap side when applicator is flipped up side down (foam tip facing up) which is incorrectly following the instructions for use (ifu).The product is conforming; the leakage occurs when the product is used incorrectly because the vent hole is on the applicator end (underneath the end cap).The purpose of the vent hole is to permit the solution to wet and drain in a controlled manner into the foam tip and to avoid pooling or dripping of solution which may be a fired hazard when used with an ignition source.Thus, the product is found conforming.The issue based on the video is the customer needs to follow the directions (instructions for use) and be aware of product label warnings.The production record review was completed for batch/lot 1048054 and no non-conformances were identified 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

It was reported by the health professional that the applicator leaked out of the bottom.Per email: i've been working in surgery for over 14 years and have been using chloraprep extensively.As much as chloraprep is used in surgery all over, i would believe that bd could design an applicator that doesn't leak out of the bottom of it every time it is used.Are your teams working on improving the design of the applicator so it doesn't leak?.

• Brand Name: CHLORAPREP UNKNOWN
• 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: 12505907
• MDR Text Key: 273560647
• Report Number: 3004932373-2021-00439
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other