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

Catalog Number 260407I

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by nhs blood and transplant.Primevigilance did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.

Event Description

Material no.: 260407, batch no.: 0149024.It was reported there was a small area of grazing to the skin after use of chloraprep applicator.Per email: i am emailing to let you know that a donor developed scratches on their arm following cleaning with a chloraprep.Wand: 'donor complained of a scratching sensation when her arm was being cleaned with chloroprep.On examination there was a small area of grazing to the skin.' chloraprep wand batch number 0149024.The wand is not available to be returned as it was disposed of at the time of the incident.Please can you feedback to qa manchester with your investigation regarding this incident.

• Brand Name: CHLORAPREP ONE-STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11224826
• MDR Text Key: 229334619
• Report Number: 3004932373-2021-00009
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 260407I
• Device Lot Number: 0149024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other