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

Catalog Number 260715

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/08/2020

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

Material no.: 260715, batch no.: 9164846.It was reported that a hair was found inside the packaging.Per email: kindly note that we received a complaint from pscc-r regarding chloraprep solution 10.5l as per below details.Product description: item: 260715.Description: chloraprep solution 10.5ml.Lot : 9164846.Expiry: 05/2022.Complaint description: "chloraprep solution 10.5ml, package is intact, and written in the package it is sterile.However, we have found "hair" inside the package.We are using it for cvc dressing which consider sterile procedure.This might result in harm to patient as it is contaminated and could cause infection to patient." affected material will be collected by sfda required actions: final analysis and investigation report are needed by sfda within 2 weeks from today date.We need to replace the defected sn.Others if you need any further information.We appreciate your feedback.

Event Description

Material no.: 260715 batch no.: 9164846.It was reported that a hair was found inside the packaging.Per email: kindly note that we received a complaint from pscc-r regarding chloraprep solution 10.5l as per below details.Product description: - item: 260715; - description: chloraprep solution 10.5ml; - lot : 9164846; - expiry : 05/2022.Complaint description: "chloraprep solution 10.5ml, package is intact, and written in the package it is sterile.However, we have found "hair" inside the package.We are using it for cvc dressing which consider sterile procedure.This might result in harm to patient as it is contaminated and could cause infection to patient.".Affected material will be collected by sfda.Required actions: - final analysis and investigation report are needed by sfda within 2 weeks from today date - we need to replace the defected sn.- others if you need any further information.We appreciate your feedback.

Manufacturer Narrative

Photos were provided for evaluation.Visual examination of the photos show the foreign matter verifying the reported issue.The hair originates from an operator.The process has certain manual processes that may result in hair on the product.The procedures/process includes preventive measures for hair in product.It is possible for associates to accidentally shed hair onto product as they are loading components into their corresponding containers/packages, although associates wear hair nets, gloves, safety glasses, and head covers; if worn improperly it could lead to the reported issue.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the manufacturing of the product.Production record review was completed with batch/lot 9164846 and no non-conformances were identified during the manufacturing process.No further actions are required at this time.This failure mode will continue to be tracked and trended.

• 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; 5175 south royal atlanta dr; tucker GA 30084
• MDR Report Key: 10960796
• MDR Text Key: 223622659
• Report Number: 3004932373-2020-00145
• 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: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: 01/31/2022
• Device Catalogue Number: 260715
• Device Lot Number: 9164846
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 01/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other