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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 WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368656
Device Problems Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 with the use of the bd vacutainer® push button blood collection set with pre-attached holder there was an issue with dirty needle stick injury while trying to retract the needle. There was no medical intervention reported.
 
Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd. Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported with the use of the bd vacutainer® push button blood collection set with pre-attached holder there was an issue with dirty needle stick injury while trying to retract the needle. There was no medical intervention reported.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Type of DeviceBLOOD SPECIMEN COLLECTION DEVICE
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 Key8184647
MDR Text Key131015362
Report Number1024879-2018-01487
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Catalogue Number368656
Device Lot Number8235582
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2018
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: 12/20/2018 Patient Sequence Number: 1
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