MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP SWABSTICK; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 260100

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

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

Part of the product was dry.

Event Description

Part of the product was dry.

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, the failure mode could not verified.Visual inspection of the retained samples was not performed based on the retained samples are visually inspected upon collection and are not packaged in the same configuration as the implicated product; therefore, are not representative of this failure mode for investigation purposes.A root cause could not be defined and no further actions are required at this time.This failure mode will continue to be tracked and trended.

• Brand Name: CHLORAPREP SWABSTICK
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10432139
• MDR Text Key: 205334284
• Report Number: 3004932373-2020-00004
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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 Catalogue Number: 260100
• Device Lot Number: 9350541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 12/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other