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

Catalog Number	367987
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® sst¿ blood collection tube experienced erroneous results.The following information was provided by the initial reporter: material no.367987, batch no.8292805.It was reported there were "spurious results." (12 of 26).Experiencing a few spurious results on different chemistry analytes.
Additional Manufacturer Narrative
Investigation summary: 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 erroneous results were observed as all results demonstrated satisfactory performance.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.Adherence to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.Specimen handling parameters should be reviewed for this tube type.Evaluation of laboratory instrumentation regarding reproducibility/repeatability may be of value.Instrument manufacturers and published data on interferences may be a useful resource.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for erroneous results with the incident lot was not observed as all samples met the required specifications.Adherence to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.Specimen handling parameters should be reviewed for this tube type.Evaluation of laboratory instrumentation regarding reproducibility/repeatability may be of value.Instrument manufacturers and published data on interferences may be a useful resource.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd vacutainer® sst¿ blood collection tube experienced erroneous results.The following information was provided by the initial reporter: material no.367987, batch no.8292805.It was reported there were "spurious results." (12 of 26).Experiencing a few spurious results on different chemistry analytes.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8569169
• Report Number: 1024879-2019-00808
• Device Sequence Number: 2091580
• Product Code: JKA
• UDI-Device Identifier: 50382903679879
• UDI-Public: 50382903679879
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (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): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 367987
• Device Lot Number: 8292805
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 90