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

Catalog Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Pr 2430563 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Chloraprep 3 ml with less chlorhexidine.Lieutenant (b)(6) reports that in the medical service, performing asepsis, they realized that when activating the chloraprep 3 ml device without dye, it had very little chlorhexidine content.For this reason, she makes a complaint to us to review what happens with the product.This product is invoiced to the pronamac customer.

Manufacturer Narrative

No samples or photos were available for evaluation.Unfortunately, as a result, bd was unable to verify the reported issue or define a probable root cause.Production record review could not be completed as the batch/lot information was not available.If additional information becomes available, the record will be reopened and investigated accordingly.No further actions are the required at this time.This failure mode will continue to be tracked and trended.

Event Description

Chloraprep 3 mlwith less chlorhexidine.Lieutenant estela gonzález reports that in the medical service, performing asepsis, they realized that when activating the chloraprep 3 ml device without dye, it had very little chlorhexidine content.For this reason, she makes a complaint to us to review what happens with the product.This product is invoiced to the pronamac customer.

• Brand Name: CHLORAPREP UNKNOWN
• 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: 11464039
• MDR Text Key: 252010137
• Report Number: 3004932373-2021-00115
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other