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

Catalog Number 930599NSB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material # 930599nsb, batch # 1104984.It was reported that there were sharps.Verbatim: the sponge stick was used on a patient and there was some sort of sharp debris in the pad that cut the patient¿s arm.Reporter information: (b)(6).Region not provided at time of entry.Complaint received on 01/27/2022.

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause at this time.If samples, photos and/or additional becomes available, bd will re-open the record and investigate accordingly.A production record review was completed for batch/lot 1104984 and there were no non-conformances related to the defect of "glass on foam or plastic body" and/or "open seal" during the manufacturing of the lot.The process failure and mode effect analysis was reviewed and 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.No further actions are required.This failure will continue to be tracked and trended.

Event Description

It was reported that there were sharps.Verbatim: the sponge stick was used on a patient and there was some sort of sharp debris in the pad that cut the patient¿s arm.Reporter information: facility name ¿ (b)(6).Region not provided at time of entry.01feb2022: the miq number for this case is (b)(4).09feb2022: kindly note that one follow-up attempt was performed for case (b)(4), but no answer was received.Next follow up attempt is scheduled on 22-feb-2022.If any new information was received, we will notify you.

• Brand Name: CHLORAPREP ONE STEP FREPP
• 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: 13502595
• MDR Text Key: 289768426
• Report Number: 3004932373-2022-00039
• 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: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 930599NSB
• Device Lot Number: 1104984
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other