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

Model Number	367987
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tube there were erroneous results.The following information was provided by the initial reporter.It was reported by the customer that they started "to see variability in some of the clinical chemistry after switching to material 367987 from material 367986.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 1062953.D4: medical device expiration date: 2022-02-28.H4: device manufacture date: 2021-03-03.H6: investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples from lot 1062953 were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure erroneous results, because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples tested were acceptable in terms of both precision and accuracy.Replicates of both retain and control samples tested demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.Based on a review of the device history record for lot 1062953, 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 erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Bd has not made any significant change to the product design of sku 367987 in the past decade.Any manufacturing changes for the stopper, tube components and finished assembly have been validated with no evidence of impact on test results for sodium or chloride 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.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tube there were erroneous results.The following information was provided by the initial reporter.It was reported by the customer that they started "to see variability in some of the clinical chemistry after switching to material 367987 from material 367986.".

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE
• Common Device Name: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12674585
• Report Number: 1024879-2021-00732
• Device Sequence Number: 19127985
• Product Code: JKA
• UDI-Device Identifier: 50382903679879
• UDI-Public: 50382903679879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 367987
• Device Catalogue Number: 367987
• Device Lot Number: 1062953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown