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

Catalog Number 260299 MX

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2020

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 is reported that 3 products from the same batch of sku 260299 mx did not have an antiseptic solution.

Manufacturer Narrative

Photos were provided for evaluation.Photos provided shows one applicator from the foam side and from the lateral wings side.Visual examination of the photo provided could not verify the reported issue as no investigation analysis can be done "insufficient solution".Unfortunately, as a result, a potential root cause could not be defined and no further actions are required at this time.Production record review was reviewed for the lot number 8304971 and no non-conformances were noted during the manufacturing of the lot.Records indicate that the product passed all the in-process inspection.No previous complaints from the same product code and lot related to the failure mode have been received from oct 2018 to oct 2020.No adverse trend observed, defect is within control limits.This failure mode will continue to be tracked and trended.

Event Description

It is reported that 3 products from the same batch of sku 260299 mx did not have an antiseptic solution.

• Brand Name: CHLORAPREP ONE-STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10743677
• MDR Text Key: 213471280
• Report Number: 3004932373-2020-00101
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• 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: 11/16/2020

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: Other
• Device Catalogue Number: 260299 MX
• Device Lot Number: 8304971
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 11/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other