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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON VACUTAINER CONTAINER, SPECIMEN, STERILE

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BECTON DICKINSON VACUTAINER CONTAINER, SPECIMEN, STERILE Back to Search Results
Model Number 34052
Device Problems Break (1069); Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2017
Event Type  malfunction  
Event Description
When drawing a lab from the hd cath, the tip of the vacutainer broke off getting stuck in the cath tip. We were unable to remove, charge nurse, clinical manager and fellow informed. Patient to go to interventional radiology (vir) for new cath placement.
 
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Brand NameVACUTAINER
Type of DeviceCONTAINER, SPECIMEN, STERILE
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr.
franklin lakes NJ 07417
MDR Report Key6685688
MDR Text Key79039959
Report Number6685688
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number34052
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2017
Event Location Hospital
Date Report to Manufacturer06/20/2017
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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