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

Event Description

Material no.: 930815.Batch no.: 1033869.It was reported by the distributor that the chloraprep applicator exploded in the or sending glass and solution throughout the suite.

Event Description

It was reported by the distributor that the chloraprep applicator exploded in the or sending glass and solution throughout the suite.

Manufacturer Narrative

25 samples were received by our quality team for evaluation.All 25 samples were inside the original unopened package with end cap locked in correct position with no defects noted and deemed conforming product (applicators and package); therefore, the incident could not be verified.Retain samples were inspected for lot # 1033869 and there were zero (0) non-conformance out of 47 conforming applicators.A device history record review found no non-conformances associated with this issue during production of this batch.Though the complaint could not be verified based on the samples received for this complaint, 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 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 12055445
• MDR Text Key: 267870522
• Report Number: 3004932373-2021-00303
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 930815
• Device Lot Number: 1033869
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other