MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORARPREP FREPP; 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 12/02/2021

Event Type  Injury  

Event Description

It was reported that patient experience skin abrasions due to sharp object embedded in chloraprep verbatim: ¿medical action industries (mai) recently received a complaint for the below incident/medical treatment with photo involving your chloraprep item# 930599nsb, lot# 1251745, that was placed in our kit.*please acknowledge receipt of this notification and respond with your investigation results as soon as possible.Date of incident: (b)(6) 2021.Quantity affected: 1 ea (1 incident).Sample availability: no sample.Customer discarded after the incident.Complaint issue: skin abrasions to top of left hand of patient caused by sharp object embedded in chloraprep from medical action iv start kit.The anesthesiologist in charge of this patient cleaned the area and applied a protective gauze.¿.

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 owens & minor.Primevigilance did reach out to obtain more information 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.

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo clearly shows scratches on a patient due to the chloraprep applicator being used.This verified the reported issue.Unfortunately, without the actual sample to analyze, a definitive root cause could not be determined at this time.A production record review was completed for batch/lot 1251745 and there were no non-conformances related to the reported issue during the manufacturing of this lot.In the event 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 patient experience skin abrasions due to sharp object embedded in chloraprep.Verbatim: ¿medical action industries (mai) recently received a complaint for the below incident/medical treatment with photo involving your chloraprep item# 930599nsb, lot# 1251745, that was placed in our kit.*please acknowledge receipt of this notification and respond with your investigation results as soon as possible.Date of incident: (b)(6) 2021.Quantity affected: 1 ea (1 incident).Sample availability: no sample.Customer discarded after the incident.Complaint issue: skin abrasions to top of left hand of patient caused by sharp object embedded in chloraprep from medical action iv start kit.The anesthesiologist in charge of this patient cleaned the area and applied a protective gauze.¿ `~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ (b)(6) 2021 per incident pv form: date of event (b)(6) 2021 @ 8:41am, skin prep before starting an intravenous line, chloraprep medication medical action iv starter kit ref 72202/lot 290602, skin abrasion to left hand caused by sharp object embedded in chloraprep fam medical action iv starter kit.No sample available , unknown pt history, event duration minutes, applied to prepare the skin before staring an intravenous line few minutes.Yes treatment interrupted patient expressed pain and burning form abrasion skin wound visible.(b)(6) 2022: i have attempted three times to try and get the customer to complete your document attached with no success or even a response.My latest attempt with this customer was yesterday.I will forward if i receive it from the customer, but uncertain we¿ll received.At this time, the complaint issue /photo is all mai has for this complaint.Complaint issue: skin abrasions to top of left hand of patient caused by sharp object embedded in chloraprep from medical action iv start kit.The anesthesiologist in charge of this patient cleaned the area and applied a protective gauze.

• Brand Name: CHLORARPREP 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: 13043134
• MDR Text Key: 284189090
• Report Number: 3004932373-2021-00537
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 930599NSB
• Device Lot Number: 1251745
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other