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

Catalog Number 930700

Device Problem Defective Device (2588)

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

Event Date 08/26/2020

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 the item was received empty.

Manufacturer Narrative

No samples or photos were received for analysis.A batch review was performed with the batch information provide and this was the first reported incident reported.As a result, a root cause cannot be defined and no corrective actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported that the item was received empty.

• 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: 10569953
• MDR Text Key: 208134490
• Report Number: 3004932373-2020-00057
• 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: 930700
• Device Lot Number: 0007670
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other