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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET INTRAVASCULAR ADMINISTRATION SET

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 367342
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. There were multiple common device names and medical device types reported to be involved. The information for each is listed below: common device name: blood specimen collection device. Medical device type: jka. Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. A review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event Description
It was reported that bd vacutainer® push button blood collection sets had issues with covers falling off, leading to clean needle-sticks. No serious injury or medical intervention reported.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7595747
MDR Text Key111341798
Report Number1024879-2018-01062
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2018
Device Catalogue Number367342
Device Lot Number6180601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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