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

Catalog Number 931490

Device Problem Defective Device (2588)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was insufficient liquid in applicator at the time of arm cleaning.

Event Description

It was reported that there was insufficient liquid in applicator at the time of arm cleaning.

Manufacturer Narrative

One sample and 5 photos were provided for evaluation.Sample was analyzed and no issues were observed on the applicator.The foam was removed to review if obstructions were located on the foam area where the solution is distributed.No issues were observed.Unfortunately, as a result, a root cause cannot be determined or no corrective actions are required at this time.This failure mode will continue to be tracked and trended.

• Brand Name: CHLORAPREP ONE STEP
• 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: 10508198
• MDR Text Key: 207038467
• Report Number: 3004932373-2020-00038
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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: Other
• Device Catalogue Number: 931490
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other