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

Catalog Number 930815NS

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 930815ns.Batch no.: reported as 324254.It was reported by the distributor that a hair was found inside the packaging.Per email: medline complaint #: (b)(4).Defect description: hair found inside of chloraprep package.Medline part #: 136713.Product description: chloraprep app 26ml orange.Vendor part #: 930815ns.Lot #: 324254.Date reported: 7/13/2021.Sample received: yes.Response needed: yes.

Event Description

Material no.: 930815ns, batch no.: reported as 324254.It was reported by the distributor that a hair was found inside the packaging.Per email: medline complaint #: (b)(4).Defect description: hair found inside of chloraprep package.Medline part #: 136713.Product description: chloraprep app 26ml orange.Vendor part #: 930815ns.Lot #: 324254.Date reported: 7/13/2021.Sample received: yes.Response needed: yes.

Manufacturer Narrative

The failure mode of foreign matter (hair) was confirmed by the photographs and sample provided by the customer for analysis.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.An initiative under the current capa is to replace labs coats with electrostatic lab coats to prevent hair from coming into the controlled manufacturing environment.Follow up emdr (b)(4).H3 other text : see narrative.

• Brand Name: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Type of Device: CHLORAPREP ONE STEP HI LITE ORANGE
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 12368863
• MDR Text Key: 268264214
• Report Number: 3004932373-2021-00417
• 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: 09/03/2021

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: 11/30/2023
• Device Catalogue Number: 930815NS
• Device Lot Number: 0324254
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other