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

Catalog Number 930400

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

When the customer was applying the chloraprep to the patient, pieces of the ampule lodged into the sponge area and the patient was cut.

Manufacturer Narrative

No samples or photos were submitted for analysis.Retained samples were reviewed and no issues were observed.As a result, the failure mode could not be verified.A probable root cause could not be defined and no corrective actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

When the customer was applying the chloraprep to the patient, pieces of the ampule lodged into the sponge area and the patient was cut.

Event Description

When the customer was applying the chloraprep to the patient, pieces of the ampule lodged into the sponge area and the patient was cut.

Manufacturer Narrative

While prepping skin for blood collection, blood noted to patient's arm.Upon inspection, a clear, hard, sharp material was noted on skin.Appears to have come from chloraprep applicator being used to prep site.No samples or photos were available for evaluation.Root cause could not be defined.A production record review was completed for batch/lot 0085419 and no non-conformances were noted during the manufacturing of this lot.No further actions are required.Bd will continue to track and trend.

• 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: 10463773
• MDR Text Key: 215381190
• Report Number: 3004932373-2020-00008
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 930400
• Device Lot Number: 85419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other