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

Model Number 367986

Device Problem False Positive Result (1227)

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

Event Date 05/03/2023

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: 'we have had a pattern of high potassium levels and when using a different lot levels were normal.".

Manufacturer Narrative

H.6.Investigation summary: bd received multiple customer return samples and 4 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for erroneous results (high k+) cannot be evaluated through photos.The customer samples were tested and no issues relating to erroneous results were observed: there were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure modes, erroneous results-potassium, because the defect was not evident in the testing of the complaint lot samples.Replicates of both customer and control samples were acceptable in terms of both precision and accuracy.All visual observations of both customer and control samples tested demonstrated clinically acceptable performance.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.The following fields were updated due to additional information: d9: device available for evaluation:  yes, d9: returned to manufacturer on: 2023-06-28.

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: 'we have had a pattern of high potassium levels and when using a different lot levels were normal.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16959452
• MDR Text Key: 315535875
• Report Number: 1024879-2023-00307
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• 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
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 3032681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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