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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER URINE COLLECTION KIT URINE SPECIMEN CUP

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BECTON DICKINSON BD VACUTAINER URINE COLLECTION KIT URINE SPECIMEN CUP Back to Search Results
Catalog Number 6630-01-505-9384
Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/21/2016
Event Type  Other  
Event Description
Pt removed yellow "do not remove label" sticker no lid of urine specimen cup and poked himself with the needle inside, causing break in his skin. Although sticker prompts user to not remove sticker, the sticker itself is a contrasting color to the lid therefore appears 'inviting'. Font on sticker is very small. Drawing on sticker is very light. Both of these may be difficult for aging eyes to read, understand. Dose or amount: 1 cup, frequency: ud. Diagnosis: urine collection.
 
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Brand NameBD VACUTAINER URINE COLLECTION KIT
Type of DeviceURINE SPECIMEN CUP
Manufacturer (Section D)
BECTON DICKINSON
franklin lakes NJ
MDR Report Key6030665
MDR Text Key57707350
Report NumberMW5065408
Device Sequence Number1
Product Code FMH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6630-01-505-9384
Device Lot NumberVARIOUS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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