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

Catalog Number 930815

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2021

Event Type  malfunction  

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.: 930815, batch no.: 0327868.It was reported the end cap of the applicator came off during activation.Pr 2 of 2: this pr is for the date of event unknown stated as "last week".Per attached complaint details: date of event: (b)(6) 2021.Product# 930815.Product description: applicator chloraprep 26ml.Lot# 0327868.Description of event: chloraprep prep stick when squeezed to activate and break the tincure lost the rear cap.This sent glass particles towards the circulators face and on the sterile field.This may not be an isolated event.Last week a similar incident occurred where the cap came loose but no glass was projected.All prep sticks with the same lot number will be sequestered from our rooms.Suspected defective product was sequestered and is available for analysis.

Event Description

It was reported the end cap of the applicator came off during activation.

Manufacturer Narrative

The facility did provide photos/samples to aid in our quality engineer¿s investigation.With the sample, provided, bd was able to confirm the failure mode as the end cap was detached from the applicator body.A device history record was reviewed, and no non-conformances was 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.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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11613985
• MDR Text Key: 266494786
• Report Number: 3004932373-2021-00167
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 930815
• Device Lot Number: 0327868
• Date Manufacturer Received: 06/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other