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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 368175
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: bd had not received samples, but seven (7) photos were provided for investigation.The photos were reviewed and the indicated failure mode for collapsed tubes with the incident lot was observed; however, the indicated failure mode for cocked stopper was not observed.While the stoppers may appear to be crooked, the reported failure mode of cocked stopper cannot be confirmed, as the stoppers are placed in the tubes correctly.The stoppers appear to be crooked due to the location of the tube collapse.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 collapsed tubes based on the photos provided; however, unconfirmed for cocked stopper based on the photos provided.The stoppers appear to be crooked due to the location of the tube collapse.Note that there are potentially varying degrees of tube collapse, based on the temperature and duration of time at elevated temperature.Mildly collapsed tubes will retain vacuum and only show minimal deformation.Mildly collapsed tubes will draw appropriately but may not be able to be processed on laboratory instruments (e.G.May be slightly bowed and no longer fit in a rack).As long as the vacuum is retained and the tube fills appropriately, the tube will function properly.Fully collapsed tubes appear flattened, twisted, and visibly deformed.Fully collapsed tubes retain little or no vacuum and therefore cannot be drawn to an appreciable volume.These tubes are easily identified before use by the healthcare worker, so there is no potential impact to the patient.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced tubes /extenders with molding defects that could be used.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: when opening the pack, it has been detect smashed tubes, and with crooked stoppers.Add info received on 06.Jan.2022: was the master box damaged? a: it did not look damaged and some of the tubes that look like crushed came in the middle of the rack, at first glance you could only see the crooked stoppers and the occasional crushed tube, i attach the first photographs.The other photos were from when the rack tubes were checked.
 
Manufacturer Narrative
Investigation summary: bd had not received samples, but seven (7) photos were provided for investigation.The photos were reviewed and the indicated failure mode for collapsed tubes with the incident lot was observed; however, the indicated failure mode for cocked stopper was not observed.While the stoppers may appear to be crooked, the reported failure mode of cocked stopper cannot be confirmed, as the stoppers are placed in the tubes correctly.The stoppers appear to be crooked due to the location of the tube collapse.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 collapsed tubes based on the photos provided; however, unconfirmed for cocked stopper based on the photos provided.The stoppers appear to be crooked due to the location of the tube collapse.Note that there are potentially varying degrees of tube collapse, based on the temperature and duration of time at elevated temperature.Mildly collapsed tubes will retain vacuum and only show minimal deformation.Mildly collapsed tubes will draw appropriately but may not be able to be processed on laboratory instruments (e.G.May be slightly bowed and no longer fit in a rack).As long as the vacuum is retained and the tube fills appropriately, the tube will function properly.Fully collapsed tubes appear flattened, twisted, and visibly deformed.Fully collapsed tubes retain little or no vacuum and therefore cannot be drawn to an appreciable volume.These tubes are easily identified before use by the healthcare worker, so there is no potential impact to the patient.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced tubes /extenders with molding defects that could be used.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: when opening the pack, it has been detect smashed tubes, and with crooked stoppers.Add info received on 06.Jan.2022: was the master box damaged? it did not look damaged and some of the tubes that look like crushed came in the middle of the rack, at first glance you could only see the crooked stoppers and the occasional crushed tube, i attach the first photographs.The other photos were from when the rack tubes were checked.
 
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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 Key13317196
MDR Text Key285843068
Report Number1024879-2022-00019
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
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
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number368175
Device Lot Number1285504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2021
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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