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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 Problems Incorrect Measurement (1383); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2020
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.(b)(4).
 
Event Description
It was reported the bd vacutainer® sst¿ blood collection tubes experienced clogged/blocked instrumentation probe and gel smearing.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated "a small amount of separation gel appeared in the serum after the vacuum tube centrifugation, and a small amount of gel was adhere to the outer wall of the sample needle during the process of drawing the serum.A certain degree of accumulation will form a separation group, which will cause the sample needle to be blocked, resulting in insufficient aspiration.Similarly, in the process of detecting ions, part of the gel entered the electrode and adhered to it with the serum, resulting in a decrease in the sensitivity of the electrode and a shortened life." adr# (b)(4).
 
Event Description
It was reported the bd vacutainer® sst¿ blood collection tubes experienced clogged/blocked instrumentation probe and gel smearing.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated "a small amount of separation gel appeared in the serum after the vacuum tube centrifugation, and a small amount of gel was adhere to the outer wall of the sample needle during the process of drawing the serum.A certain degree of accumulation will form a separation group, which will cause the sample needle to be blocked, resulting in insufficient aspiration.Similarly, in the process of detecting ions, part of the gel entered the electrode and adhered to it with the serum, resulting in a decrease in the sensitivity of the electrode and a shortened life." adr# 115153300202011025.
 
Manufacturer Narrative
H6: investigation summary bd had not received samples or photos for investigation.Therefore, 3 retention samples and 1 controls tube from bd inventory were drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1211 rcf for 10 minutes, using an mse mistral 1000 centrifuge.All 4 tubes were found to have good gel separation.1 out of 3 tubes were found to have gel smearing on the inner tube wall.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.A complaint history was performed and this was one of 3 complaints received for the reported defects.Based on the investigation performed, this complaint is confirmed for gel smearing and poor serum.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
 
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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 Key11005107
MDR Text Key226582080
Report Number1024879-2020-00925
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Model Number367986
Device Catalogue Number367986
Device Lot Number9347497
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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