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

Catalog Number 272815

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)

Patient Problems Abrasion (1689); Hypersensitivity/Allergic reaction (1907)

Event Date 10/08/2021

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

Material no: 272815, batch no: 9120671.It was reported that by the health professional after using the chloraprep applicator, small lint or scraps of skin appeared on the patient's skin.Verbatim: per google translate - during a product test at the stuttgart clinic (oa mr.Dr./omit/), after using the chloraprep applicator, small lint or scraps of skin (no closer inspection possible) appeared on the patient's skin.At first, dr./omit/ was of the opinion that small particles of the chloraprep applicator (sponge) had come off.On closer inspection of the applicator (see photo), however, it was probably only the detachment of small skin particles.There was no reaction on the patient's skin.The applicator has been tested in the clinic since wednesday and the issue did not otherwise arise.

Event Description

Material no: 272815.Batch no: 9120671.It was reported that by the health professional after using the chloraprep applicator, small lint or scraps of skin appeared on the patient's skin.Verbatim: per google translate - during a product test at the stuttgart clinic (oa mr.Dr.(b)(6)), after using the chloraprep applicator, small lint or scraps of skin (no closer inspection possible) appeared on the patient's skin.At first, dr.(b)(6) was of the opinion that small particles of the chloraprep applicator (sponge) had come off.On closer inspection of the applicator (see photo), however, it was probably only the detachment of small skin particles.There was no reaction on the patient's skin.The applicator has been tested in the clinic since wednesday and the issue did not otherwise arise.The affected batch can be found in the attached photo.

Manufacturer Narrative

Photos were received by our quality team for evaluation.Upon visual inspection it was observed that the applicator foam tip scrubbing surface does not show any defect or non-conformance; therefore, the incident could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.A root cause could not be determined based on photograph received for analysis.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see narrative below.

• Brand Name: CHLORAPREP ONE STEP HI- LITE ORANGE
• 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: 12652755
• MDR Text Key: 277430669
• Report Number: 3004932373-2021-00469
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 272815
• Device Lot Number: 9120671
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other