MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP SEPP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270449

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 03/24/2021

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 two members of the staff have had a sharps injury due to the glass breaking through the plastic.Per complaint form: i spoke to (b)(6) on the phone they are in radiology and used the chloraprep sepp that is part of the rocialle cannulation pack that is used in wales.They have used the product for a long time but two members of staff have had a sharps injury due to the glass breaking through the plastic.Also below please see the initial communication sent to me via the product manager.Contact info omitted.Business unit: infection prevention.Product line: chloraprep.Enquiry: a couple of my staff and cut their fingers recently using chloraprep sepp 0.67ml.This could be a batch issue? batch number 8264564.

Manufacturer Narrative

No photos or samples were available for evaluation.Unfortunately, as a result, bd was unable to verify the reported issue or define a root cause.If samples or photos become available, this record will be re-opened and re-assessed.Production record review was completed for batch/lot 8264564 and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.No further action will be taken based on no adverse trend observed and will continue to be tracked and trended.

Event Description

It was reported that two members of the staff have had a sharps injury due to the glass breaking through the plastic.Per complaint form: i spoke to helen on the phone they are in radiology and used the chloraprep sepp that is part of the rocialle cannulation pack that is used in wales.They have used the product for a long time but two members of staff have had a sharps injury due to the glass breaking through the plastic.Also below please see the initial communication sent to me via the product manager.Contact info omitted.Business unit: infection prevention.Product line: chloraprep.Enquiry: a couple of my staff and cut their fingers recently using chloraprep sepp 0.67ml.This could be a batch issue? batch number 8264564.

• Brand Name: CHLORAPREP SEPP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11711456
• MDR Text Key: 252358503
• Report Number: 3004932373-2021-00209
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 270449
• Device Lot Number: 8264564
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 07/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR