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

Catalog Number 930415NSB

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Imdrf annex e code health effect: (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Material no: 930415nsb batch no: 1082946.¿ it was reported that print was illegible.¿ verbatim: "on (b)(6) 2021, during final product inspection of finished good (b)(4), batch# 0061780657, quality control inspector, identified tinted cloraprep ((b)(6)) to have illegible print."label print illegible" is a major visual defect per incoming specification, (b)(4) version: (b)(4).This issue was determined to be a supplier related issue on (b)(6) 2021.This issue involves a single batch of materials: item a7509017, bbmi batch 0061791268 (vendor batch 1082946).".

Manufacturer Narrative

The batch record for pn 930415nsb, ln 1082946 was reviewed and there were no defects found during routine in-process inspections related to "illegible print".It is possible that before the printer was cleaned, some applicators with incomplete printing may have gone undetected by production and made it to the finished product bin.This is the first customer complaint received for illegible print for this product line in the last two years.There is no negative trend observed.A corrective action was implemented at the machine at the time of occurrence, no further actions are necessary at this point.Will continue to track and trend for this defect.H3 other text : see narrative section.

Event Description

Material no: 930415nsb, batch no: 1082946.  it was reported that print was illegible.  verbatim: "on 08/24/2021, during final product inspection of finished good 332103, batch# 0061780657, quality control inspector, identified tinted cloraprep (a7509017) to have illegible print."label print illegible" is a major visual defect per incoming specification, spec-md-2003980 version: 5.0.This issue was determined to be a supplier related issue on 8/31/2021.This issue involves a single batch of materials: item a7509017, bbmi batch 0061791268 (vendor batch 1082946).".

• Brand Name: CHLORAPREP ONE STEP HI LITE ORANGE
• 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: 12475280
• MDR Text Key: 271512395
• Report Number: 3004932373-2021-00431
• 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: 10/06/2021

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: 03/31/2024
• Device Catalogue Number: 930415NSB
• Device Lot Number: 1082946
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other