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

Model Number 367988

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

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 tube there was erroneous results.The following information was provided by the initial reporter.The customer stated: they are obtaining high potassium determinations on tubes 367988 lot no.2125248.Specimens were repeated and matching results were obtained.There was no hemolysis present, no history of past high values, and providers complained the high value did not fit their clinical picture.Some patients were sent to er for another blood draw.".

Manufacturer Narrative

Additional information was received: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #:2125248; d.4.Medical device expiration date: 2023-04-30; h.4.Device manufacture date: 2022-05-05.D.4.Medical device lot #:2130061; d.4.Medical device expiration date: 2023-04-30; h.4.Device manufacture date: 2022-05-10.

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tube there was erroneous results.The following information was provided by the initial reporter.The customer stated: they are obtaining high potassium determinations on tubes 367988 lot no.2125248.Specimens were repeated and matching results were obtained.There was no hemolysis present, no history of past high values, and providers complained the high value did not fit their clinical picture.Some patients were sent to er for another blood draw.".

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tube there was erroneous results.The following information was provided by the initial reporter.The customer stated: they are obtaining high potassium determinations on tubes 367988 lot no.2125248.Specimens were repeated and matching results were obtained.There was no hemolysis present, no history of past high values, and providers complained the high value did not fit their clinical picture.Some patients were sent to er for another blood draw.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for erroneous results was not observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure mode (erroneous results) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples were acceptable in terms of both precision and accuracy.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.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 is unable to be confirmed for the indicated failure mode erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE
• 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 Key: 15352110
• MDR Text Key: 305726480
• Report Number: 1024879-2022-00491
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: 50382903679886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1