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

Catalog Number UNKNOWN

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was foreign matter.

Manufacturer Narrative

No samples or photos are available for evaluation.Production record review could not be completed as limited product information was provided.Unfortunately, a potential root cause could not be defined.No corrective actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that there was foreign matter.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10772236
• MDR Text Key: 223433875
• Report Number: 3004932373-2020-00122
• Device Sequence Number: 1
• Product Code: LRJ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other