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 930815

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the sales representative that a hair was found inside the sterile packaging.Per complaint form: chloraprep applicator has a long brunette hair inside of the sterile packaging.

Manufacturer Narrative

A sample was received for investigation.One (1) sample arrived for analysis with the hair inside the original unopened package.The lot 1089458 03/2024 is printed on the applicator body and embossed on the bottomed web part of the packaging material.As a result, the reported issue was verified.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 for batch/lot 1089458 and no non-conformance was noted during the manufacturing of this lot.An initiative has been implemented to replace labs coats with electrostatic lab coats to prevent hair from coming into the controlled manufacturing environment.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported by the sales representative that a hair was found inside the sterile packaging.Per complaint form: chloraprep applicator has a long brunette hair inside of the sterile packaging.

• 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: 12109298
• MDR Text Key: 268262068
• Report Number: 3004932373-2021-00312
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: 03/31/2024
• Device Catalogue Number: 930815
• Device Lot Number: 1089458
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other