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 11/09/2021

Event Type  Injury  

Event Description

Material no.: 260407i, batch no.: 1080995.It was reported that when chloraprep was clicked to start cleaning donor's arm, a piece of glass from the vial fell onto the donors arm causing a superficial cut.Hello,we have had an arm cleaning incident where one of our operators clicked a chloraprep to start to clean the donor's arm prior to venepuncture and a piece of glass from the vial inside fell onto the donors arm causing a superficial cut.

Manufacturer Narrative

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

Manufacturer Narrative

Batch record was reviewed and there were no non-conformances related to the defect.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no.: 260407i, batch no.: 1080995.It was reported that when chloraprep was clicked to start cleaning donor's arm, a piece of glass from the vial fell onto the donors arm causing a superficial cut.Verbatim: hello,we have had an arm cleaning incident where one of our operators clicked a chloraprep to start to clean the donor's arm prior to venepuncture and a piece of glass from the vial inside fell onto the donors arm causing a superficial cut.Chloraprep lot number 1080995, exp 03/2024kind regards.

• 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: 12861307
• MDR Text Key: 281150070
• Report Number: 3004932373-2021-00499
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 260407I
• Device Lot Number: 1080995
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• 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