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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP SWABSTICK; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
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CAREFUSION 213, LLC 0113 CHLORAPREP SWABSTICK; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number 260100B
Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
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 no: 260100b, batch no: 1187812.It was reported that applicators in packaged affected materials are dry.Verbatim: 2879 ea.Of part number cs260100b- bd # 260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.
 
Event Description
Material no: 260100b, batch no: 1187812.It was reported that applicators in packaged affected materials are dry.Verbatim: 2879 ea.Of part number cs260100b- bd # 260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.Video and information.Part number: cs260100b; lot number: 1187812; po: (b)(4); qty: (b)(4); unit cost: (b)(4); total cost: (b)(4); total $ (b)(4).Please let us know how to disposition this product with a cod and credit or provide a return authorization for this discrepant material.Per email: i send this email to notify that (b)(4) ea.Of part number cs260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.Video and information: part number: cs260100b; lot number: 1187812; po: (b)(4); qty: (b)(4); unit cost: (b)(4); total cost: $ (b)(4); total $ (b)(4).Please reach to the supplier to get a disposition for this discrepant material.
 
Manufacturer Narrative
Please note that the annex a code was entered incorrectly on the initial mdr, this supplemental holds the correct a codes a0203 - defective device (2588) the root cause can be attributed to our equipment as the solution ran low on the thank during fill.We have taken corrective actions such as training technicians and assembly associates about this failure mode and how to correct the failure if it were to occur again.Production batch history records for applicator pn (b)(4) lot number 1187812 were reviewed and a bounding was reported for missing solution defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see below.
 
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Brand Name
CHLORAPREP SWABSTICK
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 Key12667129
MDR Text Key277745840
Report Number3004932373-2021-00472
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number260100B
Device Lot Number1187812
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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