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

Catalog Number 930500NSB

Device Problem Defective Device (2588)

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

Event Date 06/08/2021

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.: 930500nsb.Batch no.: 0326686.It was reported by the distributor that the sponges of the chloraprep applicators are not becoming wet once activated.Per distributor: the customer says it¿s the same issue as before, solution in the ampoules and the sponge did not soak.Per email: i just received an email today from this customer they had an additional 10 ea of the same chloraprep issue with the same raw lot, 0326686.This is now a total of 48 each affected for this complaint.Very unusual high amount for this type of issue.They were just saving the kit labels, but just informed them to see if they can get us a few affected chlorapreps, or a few unopened kits where we can pull out the preps to send you.So far, no samples.

Manufacturer Narrative

The batch record for pn 930599nsb, ln 0326686, was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.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.

Event Description

It was reported by the distributor that the sponges of the chloraprep applicators are not becoming wet once activated.

• Brand Name: CHLORAPREP ONE STEP
• 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: 12075867
• MDR Text Key: 267868850
• Report Number: 3004932373-2021-00306
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 930500NSB
• Device Lot Number: 0326686
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other