MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP ONE-STEP HI-LITE 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 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Pr (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 particulate.

Event Description

Material no.: 930815ns, batch no.: 0287124.It was reported by the distributor that there was particulate.Per report: foreign particle.

Manufacturer Narrative

Failure mode is not confirmed since no evidence was provided by customer.Production batch history records for applicator pn 930815ns lot number 0287124 was 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.A definite root cause can't be identified without an actual sample or a picture of the defect.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the packaging of the product.No further action will be taken based on a negative trend is not observed at this time.H3 other text : see narrative below.

• 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 12337573
• MDR Text Key: 267105245
• Report Number: 3004932373-2021-00393
• 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: 09/15/2021

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: 10/31/2023
• Device Catalogue Number: 930815NS
• Device Lot Number: 0287124
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/17/2021
• Patient Sequence Number: 1