MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP SEPP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270449

Device Problem Defective Device (2588)

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

Event Date 09/13/2021

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

It was reported by the facility representative that the liquid does not impregnate the sponge making it unusable.Per complaint form: the customer stated that in a couple of occasions when breaking the seal of bd chloraprep the liquid does not impregnate the sponge and you cannot use it.Unable to use product, leading to waste as another chloraprep device has to be used.

Event Description

It was reported by the facility representative that the liquid does not impregnate the sponge making it unusable.Per response form: both ampule and packaging were intact.Per complaint form: the customer stated that in a couple of occasions when breaking the seal of bd chloraprep the liquid does not impregnate the sponge and you cannot use it.Unable to use product, leading to waste as another chloraprep device has to be used.

Manufacturer Narrative

No samples or photos were provided for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause.A production record record was not completed as the batch/lot information was not available.If samples, photos or additional information become available, this record will be re-opened and investigated appropriately.No further actions are required.This failure will continue to be tracked and trended.

• Brand Name: CHLORAPREP ONE STEP SEPP
• 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: 12586003
• MDR Text Key: 276477266
• Report Number: 3004932373-2021-00460
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 270449
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other