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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367812
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out/ loose closure.This event occurred 10,000 times.The following information was provided by the initial reporter.The customer stated: customer noticed that the tube cap was not fit, it is very loose on the tube and often falls down.The circumstances that they have had this issue while sampling collection, centrifugation, and sample processing.Due to these issues, they had faced accidents a few times dropping the tubes and lost the serum and whole blood which leads to asking for a repeat sample from the patients and it affects our turnaround time.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-mar-2022.H.6.Investigation: bd received five (5) samples and one (1) video for investigation.The video was reviewed and the indicated failure mode for decapping was observed, as it shows the tube assembly being held by the hemogard shield and the tube falling out of the hemogard shield as it becomes unattached.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for decapping with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint has been confirmed for the indicated failure mode of decapping based on the returned sample testing and video.Bd has initiated further root cause investigation relating to the issue of stopper function defects through capa#1875009.
 
Event Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out/ loose closure.This event occurred 10,000 times.The following information was provided by the initial reporter.The customer stated: customer noticed that the tube cap was not fit, it is very loose on the tube and often falls down.The circumstances that they have had this issue while sampling collection, centrifugation, and sample processing.Due to these issues, they had faced accidents a few times dropping the tubes and lost the serum and whole blood which leads to asking for a repeat sample from the patients and it affects our turnaround time.
 
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Brand Name
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
Type of Device
BLOOD 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13476882
MDR Text Key286265676
Report Number1024879-2022-00068
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903678129
UDI-Public00382903678129
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
BK050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2022
Device Catalogue Number367812
Device Lot Number1081112
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2022
Initial Date FDA Received02/07/2022
Supplement Dates Manufacturer Received04/12/2022
Supplement Dates FDA Received04/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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