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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. CHLORAPREP ONE-STEP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE
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BECTON, DICKINSON & CO. CHLORAPREP ONE-STEP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE Back to Search Results
Model Number 260400
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Event Description
Nurse was placing a peripherally inserted central catheter (picc) and prepared sterile field by dropping a chloraprep one-step onto the field.During placement, the nurse attempted to cleanse the site.When the chloraprep was attempted to be utilized, the nurse snapped the wings to release the fluid but there was no snap and then the nurse noted that there was no fluid in the chamber.Another nurse dropped another chloraprep onto the field, and when the nurse went to use this cleanser device, the same occurred requiring a third chloraprep to be utilized.Both prior chlorapreps came from the same lot number.
 
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Brand Name
CHLORAPREP ONE-STEP
Type of Device
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Manufacturer (Section D)
BECTON, DICKINSON & CO.
one becton drive
franklin lakes NJ 07417
MDR Report Key8627066
MDR Text Key145620520
Report Number8627066
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/03/2019
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 Model Number260400
Device Catalogue Number260400
Device Lot Number8331695
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2019
Event Location Hospital
Date Report to Manufacturer05/21/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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