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

Catalog Number 270449

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 08/24/2020

Event Type  Injury  

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 broken glass from inside the barrel came out and cut the user's hand.

Event Description

It was reported that broken glass from inside the barrel came out and cut the user's hand.

Manufacturer Narrative

No samples or photos were received for evaluation.Unfortunately, as a result, the root cause could not be determined and the failure mode could not be verified at this time.Historical trend has shown that this failure mode may occur due to the design when multiple activation occurs.Instructions for use specify that to activate applicator it needs to be squeezed gently ¿only once¿.If the applicator was pinched several times this could be the probable cause for the failure mode.No further actions will be taken based on the failure mode not being confirmed.

• Brand Name: CHLORAPREP SEPP
• 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: 10463755
• MDR Text Key: 215379808
• Report Number: 3004932373-2020-00009
• 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: foreign,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 270449
• Device Lot Number: 9217468
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other