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 08/18/2020

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

Manufacturer Narrative

Five samples were returned from the customer for analysis, four of them were already activated and one of them was not activated.Ampoule from the applicator not being activated was removed from the applicator and weighed.The weight of the complaint ampoule was 2.420g.According to batch records, specifications for this ampoule lot was 2.265g (lower spec) and 2.530g (upper spec).Complaint sample was found within specification.Based on manufacturing batch records and retain samples, no issues related to the complaint were noticed based on complaint sample received and the failure mode 'solution not enough' cannot be confirmed.No further actions are required at this time.Complaints will continue to be tracked and trended.

Event Description

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

• 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: 10510827
• MDR Text Key: 207038591
• Report Number: 3004932373-2020-00040
• 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: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other