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 273415

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/16/2021

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

It was reported by the pharmacist that the product has leaked out inside the packaging.Verbatim: received phone call from hospital pharmacist reporting 9 faulty chloraprep 3ml ref (b)(4).She stated that the device does not contain a lot of product.She stated that there is a leakage as the applicator contains products while it is sealed in its packaging.Batch number 0337048 and expiry date 11-2023.Products are available if retrieval is needed for investigation.

Manufacturer Narrative

Photos were provided for evaluation.Visual examination of the photos shows activated 3ml applicators.The orange stains in applicator's foam is evidence that the applicator has been activated.This verifies the reported issue of pre-activation.The most probable root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate and break the glass ampoule.Due to the nature of glass it is possible to have an activated applicator and/or broken ampoule if the applicator undergoes excessive handling.Without the actual samples, bd is unable to determine a definitive root cause based on photos alone.The batch record for (b)(4) ln 0337048 was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.No further action will be taken.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported by the pharmacist that the product has leaked out inside the packaging.Verbatim: received phone call from hospital pharmacist reporting 9 faulty chloraprep 3ml ref 273415.She stated that the device does not contain a lot of product.She stated that there is a leakage as the applicator contains products while it is sealed in its packaging.Batch number 0337048 and expiry date 11-2023.Products are available if retrieval is needed for investigation.

• 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: 12307121
• MDR Text Key: 266008676
• Report Number: 3004932373-2021-00366
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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: 273415
• Device Lot Number: 0337048
• Date Manufacturer Received: 08/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other