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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 367988
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Test Result (2695); No Code Available (3191)
Event Date 03/18/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).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 that an unspecified number of bd vacutainer® sst¿ blood collection tubes experienced erroneous results and poor barrier separation of sample.Product defects were noted during use.The following information was provided by the initial reporter: material no.367988, batch no.9353989.Complaint 2 of 2.On (b)(6) 2020, i was at customer site to perform troubleshooting.Hyperkalemia experienced at two sites.According to the customer, the samples are collected using best practices and following instructions for use, determined via internal customer observations.Elevated potassium samples are repeated and yield same falsely elevated results.Once patient is sent to the emergency room, potassium results are normal.Internal customer's investigation has determined the cause of the falsely elevated potassiums to be from the increased red cells caught on top of the gel and in between the gel barrier.The customer agreed to bd performing a paqc to further assist in the investigation.
 
Event Description
It was reported that an unspecified number of bd vacutainer® sst¿ blood collection tubes experienced erroneous results and poor barrier separation of sample.Product defects were noted during use.The following information was provided by the initial reporter: material no.367988, batch no.9353989.Complaint 2 of 2.On (b)(6) 2020, i was at customer site to perform troubleshooting.Hyperkalemia experienced at two sites.According to the customer, the samples are collected using best practices and following instructions for use, determined via internal customer observations.Elevated potassium samples are repeated and yield same falsely elevated results.Once patient is sent to the emergency room, potassium results are normal.Internal customer's investigation has determined the cause of the falsely elevated potassiums to be from the increased red cells caught on top of the gel and in between the gel barrier.The customer agreed to bd performing a paqc to further assist in the investigation.
 
Manufacturer Narrative
Investigation: bd received samples from the customer facility for investigation.The customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The customer and retention samples were tested and no issues relating to elevated potassium, erroneous results and poor barrier separation were observed as all results demonstrated satisfactory performance.Replicates of analytes for both customer and control samples tested were acceptable in terms of both precision and accuracy.Visual evaluations for rbc¿s on barrier were not significant.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.
 
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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 Key9934395
MDR Text Key188658995
Report Number1024879-2020-00252
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903679886
UDI-Public50382903679886
Combination Product (y/n)N
PMA/PMN Number
BK050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Model Number367988
Device Catalogue Number367988
Device Lot Number9353989
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2020
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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