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

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930815.Batch no.: unknown.It was reported by the sales representative that the back end fell off causing the glass to break into the surgical field and onto patient.If the problem is corrected.Was new product shipped out to replace the product that was recalled.No date of incident was given.She should have it in their system broken glass and solution went into the surgical field and on to the patient.

Event Description

It was reported by the sales representative that the back end fell off causing the glass to break into the surgical field and onto patient.

Manufacturer Narrative

Your facility did provide not photos/samples to aid in our quality engineer¿s investigation.With the lack of samples provided, bd was unable to confirm the failure mode as the end cap was detached from the applicator body.A device history record could not be evaluated as the lot number is unknown.Although the complaint could not be confirmed, 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 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.

• 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
• MDR Report Key: 11956396
• MDR Text Key: 267866234
• Report Number: 3004932373-2021-00278
• 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: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 930815
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other