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

Catalog Number 260599NSB

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 07/28/2020

Event Type  Injury  

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 after scrubbing patients forearm several times, blood and a superficial laceration to the site was noticed.When the applicator was inspected a small, sharp material was noticed on the sponge.

Event Description

It was reported that after scrubbing patients forearm several times, blood and a superficial laceration to the site was noticed.When the applicator was inspected a small, sharp material was noticed on the sponge.

Manufacturer Narrative

One sample was sent by the customer for evaluation.Sample was analyzed and no evidence of any sharp components were observed on the scrub (foam) side.The foam was removed from the plastic body in order to further review the condition of the plastic hinge (flap) that holds the glass from being exposed into the foam.No issues were observed with the hinge (flap).This component was properly placed with no damaged and holding all broken glass.As a result, the failure mode reported cannot be confirmed and no root cause can be defined at his time.No corrective actions are required and similar complaints will continue to be track 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: 10463713
• MDR Text Key: 215380726
• Report Number: 3004932373-2020-00007
• Device Sequence Number: 1
• Product Code: KXF
• 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: Modification/Adjustment
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260599NSB
• Device Lot Number: 9213703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other