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 930815NS

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material 930815ns - batch #1138175.It was reported that there was foreign matter found in the packaging.Email verbatim: ¿yesterday a hair was found in one of their gyn packs on the prep applicator.The pack was not saved during the rapid turnover as the patient was being brought back to the operating room.There was a 5 minute delay in the case." no further information provided at time of entry.Chloraprep ¿ product # 930815ns.

Event Description

Material 930815ns - batch #1138175.It was reported that there was foreign matter found in the packaging.Email verbatim: ¿yesterday a hair was found in one of their gyn packs on the prep applicator.The pack was not saved during the rapid turnover as the patient was being brought back to the operating room.There was a 5 minute delay in the case." no further information provided at time of entry.Chloraprep ¿ product # 930815ns.External reference #(b)(4).

Manufacturer Narrative

The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the packaging of the product.Gowning procedures require operators to wear hair nets, gloves, safety glasses and head covers.If protective equipment is worn improperly it is possible for associates to accidentally shed hair onto the product as they are loading components into their corresponding containers/packages.An initiative under our current capa is to replace lab coats to prevent hair from coming into the controlled manufacturing environment.Anti-electrostatic coats started to be implemented on (b)(6)2021.Bd will continue to track and trend.H3 other text : see narrative below.

• 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
• 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: 13192279
• MDR Text Key: 290138143
• Report Number: 3004932373-2021-00554
• Device Sequence Number: 1
• Product Code: KXF
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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: 05/31/2024
• Device Catalogue Number: 930815NS
• Device Lot Number: 1138175
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1