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

Catalog Number 261815

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

The obstetrics department when opening the chloraprep for a procedure found a hair inside the packaging.

Manufacturer Narrative

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

Event Description

The obstetrics department when opening the chloraprep for a procedure found a hair inside the packaging.

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.A production record review was completed for batch/lot 1063784 and no non-conformance was noted during the manufacturing of this lot.A corrective action initiative has been developed to replace lab coats with electrostatic lab coats to prevent hair from coming into the controlled manufacturing environment.This failure will continue to be tracked and trended.H3 other text : see narrative below.

• 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: 12870247
• MDR Text Key: 283173553
• Report Number: 3004932373-2021-00505
• Device Sequence Number: 1
• Product Code: KXF
• UDI-Device Identifier: 50885403232709
• UDI-Public: (01)50885403232709
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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: 02/29/2024
• Device Catalogue Number: 261815
• Device Lot Number: 1063784
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other