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

Catalog Number 260299 MX

Device Problems Labelling, Instructions for Use or Training Problem (1318); Missing Information (4053)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

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

Let me tell you that we received the 1.5 ml chloraprep (260299) under the following conditions: it seems that some label has come off.We did not receive any notification that the product would come this way.

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo shows a removed label on an outer packaging of the applicator.Unfortunately, bd was unable to verify the reported issue as individual frepp packaging does not include any labeling.This label could be attached to the product in post-assembly/packaging processes.This kind of label shown in the photo does not match any labels used in the bd el paso manufacturing process.The most probable root cause can be related to a product manipulation post-assembly/packaging process.Production record review was completed with batch/lot: 8304971 and no non-conformance was noted during the manufacturing of lot.Awareness training was performed to the assembly/packaging associates at the manufacturing site.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text: see narrative below.

Event Description

Let me tell you that we received the 1.5 ml chloraprep (260299) under the following conditions: it seems that some label has come off.We did not receive any notification that the product would come this way.Please inform us when we have a similar situation, since there is a danger that the institutions may place any objection to us when receiving the product.

• 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: 11365760
• MDR Text Key: 268149513
• Report Number: 3004932373-2021-00068
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• 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: 05/04/2021

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: 10/31/2021
• Device Catalogue Number: 260299 MX
• Device Lot Number: 8304971
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other