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

Catalog Number 930415

Device Problem Defective Device (2588)

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

Event Date 08/31/2020

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

It was reported that the applicator was dried out.

Event Description

It was reported that the applicator was dried out.

Manufacturer Narrative

No samples or photos were available for evaluation.Tracking information was provided and confirmed its delivery at the site.Unfortunately, quality engineers at the site verified that no sample was available for analysis.Retained samples were reviewed and no issue were observed.Batch records were reviewed for the lot number 9344810 and no non-conformances were noted during the manufacturing of this lot.Records indicate that the reviewed batch record passed all the in-process inspection.No potential root cause or corrective actions are required at this time.This failure mode 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10592999
• MDR Text Key: 208758319
• Report Number: 3004932373-2020-00063
• 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: 930415
• Device Lot Number: 9344810
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other