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

Catalog Number 930815NS

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.

Event Description

It was reported by the distributor that there was a hair.

Event Description

Material no.: 930815ns batch no.: 0266654.It was reported by the distributor that there was a hair.Per report: hair.

Manufacturer Narrative

Failure mode is confirmed for this complaint by photos provided.Production batch history records for applicator pn 930815ns lot number 0266654 were reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.Records reviewed indicate that the lot passed all the in-process inspections.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the packaging of the product.

• Brand Name: CHLORAPREP ONE-STEP HILITE ORANGE
• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12336297
• MDR Text Key: 267060880
• Report Number: 3004932373-2021-00377
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

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: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 930815NS
• Device Lot Number: 0266654
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1