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

Model Number	367981
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2020
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.(b)(4).
Event or Problem Description
It was reported the bd vacutainer® sst¿ blood collection tubes experienced poor barrier separation of sample.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the red cells do not separate from the serum after being spun down, also tubes appear to have something clear and solid inside (fibrin).This is the second batch of these where the rbc do not separate from the serum during spin down process - or it separates, but not fully.Customer has already reported another batch and has no resolution from vendor.Customer is frustrated as no other brand of these is on the market.Says there appears to be something clear and solid on the inside of the tubes that was not present with the brand they used to use." on (b)(6) 2020 spoke with the customer, and the facility tests horse blood.They switched from another company to the bd sst tubes and are getting big fibrin clots after centrifugation.She does not know the speed or time, as she does not work in the lab.I explained that these tubes are for human blood, and explained the handling and processing steps, and stated that we do not have any data for animals for our tubes.She would need to validate her processing steps for horses.Link to the ifu and the sst processing tech talk was sent.

• 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: 11187497
• Report Number: 1024879-2021-00038
• Device Sequence Number: 3815562
• Product Code: JKA
• UDI-Device Identifier: 50382903679817
• UDI-Public: 50382903679817
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 01/11/2021

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: 08/31/2021
• Device Model Number: 367981
• Device Catalogue Number: 367981
• Device Lot Number: 0232219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1