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

Catalog Number 930599NSB

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

Patient Problem Abrasion (1689)

Event Date 01/25/2022

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 chloraprep pad released a sharp and cut nurse.Verbatim: a prep pad applicator released a sharp part that cut a nurse yesterday.

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 chloraprep pad released a sharp and cut nurse.Verbatim: a prep pad applicator released a sharp part that cut a nurse yesterday.

Event Description

It was reported that chloraprep pad released a sharp and cut nurse.Verbatim: a prep pad applicator released a sharp part that cut a nurse yesterday.Thu 2/3/2022 6:01 am: thank you for your email, i hereby confirm receipt.Please kindly note that assigned pv id number is (b)(4) (initial).

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo did not provide enough detailed information to verify the reported issue.Without the actual sample available for analysis, the definitive root cause could not be defined.In the event that the foam is not welded correctly onto the body of the applicator, it is possible there is an open seal that may result in exposed glass and potential for cuts and scratches.A production record review was not completed as the batch/lot information was unavailable.No further action is required.This failure will continue to be tracked and trended.

Manufacturer Narrative

A sample was provided for evaluation.Visual examination of the sample did not present traces of glass on the foam and there was no evidence of a missing or incomplete weld.The process failure and mode effect analysis was reviewed and there are two potential failure modes that could result in cuts or scratches.The first one is "missing or an incomplete weld." in the event that the foam is not welded correctly onto the body it is possible there is an open seal that may result in exposed glass and therefore in potential cuts and scratches.The second one is "glass on exterior of applicator." in the event that an ampoule breaks during the assembly process and the machine is not adequately cleaned it is possible that a piece of glass may attach itself to the exterior of the applicator.As a result, bd was unable to verify the reported issue and a definitive root cause could not be defined at this time.A production record review could not be completed as the batch/lot information was unavailable.No further actions are required.This failure will continue to be tracked and trended.

Event Description

It was reported that chloraprep pad released a sharp and cut nurse.Verbatim: a prep pad applicator released a sharp part that cut a nurse yesterday.Thu (b)(6) 2022 6:01 am.Thank you for your email, i hereby confirm receipt.Please kindly note that assigned pv id number is (b)(4)(initial).

• Brand Name: CHLORAPREP ONE STEP
• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13524208
• MDR Text Key: 285549987
• Report Number: 3004932373-2022-00046
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 930599NSB
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other