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

Catalog Number NS930700

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No samples or photos were provided for evaluation.Unfortunately, as a result, bd was unable to verify the reported issue.The hair originates from an operator.The process has certain manual processes that may result in hair on the 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 1078273 and no non-conformance was noted during the manufacturing of this lot.An initiative is to replace lab coats with electrostatic lab coats to prevent hair from coming into the controlled manufacturing environment.No further action will be taken at this time and bd will continue to be tracked and trended.

Event Description

It was reported by the facility representative that a hair was discovered inside the sealed package.Per email; i wanted to bring to your attention a situation regarding a compromised chloraprep clear, cat# lot#1078273.Before opening the package, a hair was discovered inside.Fortunately it was noted before opening.Can you please confirm if there have been any other incidents reported?.

• Brand Name: CHLORAPREP ONE STEP
• 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
• 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: 12198024
• MDR Text Key: 262509717
• Report Number: 3004932373-2021-00335
• Device Sequence Number: 1
• Product Code: KXG
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2021

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: 03/31/2024
• Device Catalogue Number: NS930700
• Device Lot Number: 1078273
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other