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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VACUATINER PLASTIC K2EDTA TUBE 6 ML
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BD BD VACUATINER PLASTIC K2EDTA TUBE 6 ML Back to Search Results
Catalog Number 367873
Device Problem Scratched Material (3020)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 04/15/2014
Event Type  Injury  
Event Description
It was reported that while using a 6 ml bd vacutainer plastic k2edta tube, a phlebotomist injured his/her finger on a sharp spike at the end of the tube while pushing it onto a needle.The phlebotomist required two surgeries to remove granulated tissue on his/her right thumb and was absent from work for more than three months.
 
Manufacturer Narrative
A sample is not available for evaluation.The device history record will be reviewed and upon completion of the investigation, a supplemental report will be filed.
 
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Brand Name
BD VACUATINER PLASTIC K2EDTA TUBE 6 ML
Type of Device
EDTA TUBE
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417 188
Manufacturer (Section G)
BELLIVER INDUSTRIAL ESTATE
plymouth PL6 7BP
UK   PL6 7BP
Manufacturer Contact
aaron larson
1 becton dr.
franklin lakes, NJ 07417-1880
8015652406
MDR Report Key4258864
MDR Text Key5049829
Report Number2243072-2014-00282
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number367873
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/27/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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