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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET Back to Search Results
Catalog Number 367344
Device Problem Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that after performing blood collection using a bd vacutainer® push button blood collection set; when activating the button, the front/rear barrel separated. There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Reportability: additional information was received clarifying the event of this complaint. The product was found separated before use. Bdj received an actual sample and confirmed the product was separated. Also, one transparent part was found to be broken. Based on the aforementioned, this complaint is not a reportable event.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceBLOOD COLLECTION SET
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7554212
MDR Text Key109629285
Report Number1710034-2018-00243
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K030573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2019
Device Catalogue Number367344
Device Lot Number7275949
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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