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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
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CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number 270815
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Imdrf annex e code health effect: clinical code: (b)(4) no clinical signs, symptoms or conditions.Imdrf annex f code health effect: impact code: (b)(4) no patient involvement or (b)(4).Annex a: (b)(4): defective device.(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
 
Event Description
Material no.: 270815 batch no.: 0336034/0342977/014384.It was reported by the distributor that the applicator does not have any body prep solution.Per complaint form: a member of staff informed simon that the bd chloraprep with tint doesn't have any body prep solution in them, or some have leaked.I have listed the batch numbers that seem to be affected.
 
Event Description
Material no.: 270815 batch no.: 0336034/0342977/014384.It was reported by the distributor that the applicator does not have any body prep solution.Per complaint form: a member of staff informed simon that the bd chloraprep with tint doesn't have any body prep solution in them, or some have leaked.I have listed the batch numbers that seem to be affected.
 
Manufacturer Narrative
No sample or photograph was received for analysis; therefore, the failure mode could not be confirmed, nor the root cause be determined.No non-conformance was noted during the manufacturing of these lots.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.
 
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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 Key12512590
MDR Text Key272690982
Report Number3004932373-2021-00440
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number270815
Device Lot NumberUNKNOWN
Date Manufacturer Received10/06/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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