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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367986
Device Problem Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
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 when using the bd vacutainer® sst¿ blood collection tubes there was poor barrier separation of sample.The following information was provided by the initial reporter: translated to english.The customer stated: it was reported that there was poor barrier separation and fibrin.We have a thermo fisher sorval st16r.We get 2442 rpm¿s when spinning serum/plasma tubes at 1100 rcf.We have the same braking time as carberry.We have all serum tubes clot for a minimum of 30 minutes.Majority of samples collected in phlebotomy room attached to lab by a variety of technologist¿s, as well as on our ward.".
 
Event Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes there was poor barrier separation of sample.The following information was provided by the initial reporter: translated to english.The customer stated: it was reported that there was poor barrier separation and fibrin.We have a thermo fisher sorval st16r.We get 2442 rpm¿s when spinning serum/plasma tubes at 1100 rcf.We have the same braking time as carberry.We have all serum tubes clot for a minimum of 30 minutes.Majority of samples collected in phlebotomy room attached to lab by a variety of technologist¿s, as well as on our ward.".
 
Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 10 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation and fibrin was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to poor barrier separation and fibrin were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure, poor barrier and fibrin, because the defect was not evident in the testing of the complaint lot samples.Visual evaluations of both complaint lot (retains) and control samples demonstrated clinically acceptable performance for all visual observations evaluated.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 issues during manufacturing of the product.This complaint has been confirmed for poor barrier separation and fibrin based on the photos provided.H3 other text : see h.10.
 
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Brand Name
BD VACUTAINER SST BLOOD COLLECTION TUBES
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key11467097
MDR Text Key249017110
Report Number1024879-2021-00175
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903679862
UDI-Public50382903679862
Combination Product (y/n)N
PMA/PMN Number
BK050036
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 05/20/2021
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 Date04/30/2021
Device Model Number367986
Device Catalogue Number367986
Device Lot Number0129752
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/19/2021
Initial Date FDA Received03/11/2021
Supplement Dates Manufacturer Received05/20/2021
Supplement Dates FDA Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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