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

Catalog Number 260407I

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

Patient Problem Abrasion (1689)

Event Date 12/17/2021

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 small scratches on donor's arm, small shards of glass evident all over donors arm and floor.Verbatim: chloraprep.Received via: email on 17-dec-2022 no case created until 18-jan-2022.Arm scratches occurred from chloroprep wand, 10-15 secs into process sponge detached and glass noticed, sponge also had a split which resulted in small scratches on donor's arm, on lifting chloraprep small shards of glass evident all over donors arm and floor.Chloroprep details.Chloroprep 1155597, exp.05/24.Please send investigation details and response to ¿omitted.Unfortunately due to current pandemic situation we are unable to return the cloroprep wand and no photo provided by team.On 20-jan-2022: thank you for your email, i hereby confirm receipt.Please kindly note that assigned pv id number is (b)(4).

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue and determine a defined root cause at this time.A production record review was completed for batch/lot 1155597 and there were no non-conformances related to the defect of 'open seal' during the manufacturing of the lot.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 many result in potential cuts and/or scratches.Unfortunately, samples are required to make this determination.No further actions are required.This failure mode will continue to be tracked and trended.

Event Description

It was reported that small scratches on donor's arm, small shards of glass evident all over donors arm and floor.Verbatim: chloraprep.Received via : email on 17dec2022 no case created until 18jan2022.Arm scratches occurred from chloroprep wand, 10-15 secs into process sponge detached and glass noticed, sponge also had a split which resulted in small scratches on donor's arm, on lifting chloraprep small shards of glass evident all over donors arm and floor.Chloroprep details.Chloroprep 1155597 exp.05/24.Please send investigation details and response to ¿/ommited/.Unfortunately due to current pandemic situation we are unable to return the cloroprep wand and no photo provided by team.20-jan-2022 thank you for your email, i hereby confirm receipt.Please kindly note that assigned pv id number is (b)(4).

• 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: 13310711
• MDR Text Key: 289182621
• Report Number: 3004932373-2022-00008
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 27613203022112
• UDI-Public: (01)27613203022112
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260407I
• Device Lot Number: 1155597
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other