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 930815

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 07/13/2021

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

It was reported that the nurse squeezed then shook chloraprep stick - the end on the prep stick flew off and the glass cylinder flew out of the end of the handle towards the nurse and patient.Verbatim: describe the event or problem: nurse propping patient's right arm for av fistula.Sterile scrub prep completed.Nurse squeezed then shook chloraprep stick.The end on the prep stick flew off and the glass cylinder flew out of the end of the handle towards the nurse's right shoulder and cheek.The glass shattered on the nurse and shards of glass fell on the sterile surgical field and on the patient.The sheet under the patient's arm was removed which contained glass shards.The patient's arm was inspected thoroughly by both rns m or.Several small shards removed from patient's arm.No visible harm to patient.Rn had minor cuts to right middle finger.What was the original intended procedure? : av fistula what problem did the user have (check all that apply).Device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do.

Event Description

It was reported that the nurse squeezed then shook chloraprep stick - the end on the prep stick flew off and the glass cylinder flew out of the end of the handle towards the nurse and patient.Verbatim: describe the event or problem: nurse propping patient's right arm for av fistula.Sterile scrub prep completed.Nurse squeezed then shook chloraprep stick.The end on the prep stick flew off and the glass cylinder flew out of the end of the handle towards the nurse's right shoulder and cheek.The glass shattered on the nurse and shards of glass fell on the sterile surgical field and on the patient.The sheet under the patient's arm was removed which contained glass shards.The patient's arm was inspected thoroughly by both rns m or.Several small shards removed from patient's arm.No visible harm to patient.Rn had minor cuts to right middle finger.What was the original intended procedure? : av fistula what problem did the user have (check all that apply).Device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do;.

Manufacturer Narrative

Your facility did not provide photos/samples to aid in our quality engineer¿s investigation.As a result, bd was unable to verify the reported issue.A device history review was completed for batch/lot 0328213 and no non-conformances were noted during the manufacturing of this lot.The root cause is attributed to the equipment station for the end cap placement unto the applicator body.Corrective actions were initiated which led to bd conducting a voluntary recall on certain lots of the chloraprep hi-lite orange 26 ml applicator.Bd has confirmed that some of the product, which included this lot, had an applicator end cap that was improperly secured during the manufacturing process which resulted in broken glass dropping out of the applicator.Your facility should have received a recall notification for this failure, and it is also attached to this email.Please ensure that your facility completes the customer response form associated with the recall and follows the directions provided.Bd recognizes that customers place their trust in our products, and we strive to exceed the expectations of every customer.Your feedback is essential to our mission to improve the productivity and safety of health care globally.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: 12690463
• MDR Text Key: 278422414
• Report Number: 3004932373-2021-00479
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 930815
• Device Lot Number: 0328213
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other