MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366882
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Material #: 368498.Lot/batch #: 1330507.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for poor barrier separation was observed.Additionally, retention samples from bd inventory were evaluated by functional testing and the issue of poor barrier separation was not observed.4 retained samples from the same lot number were, therefore, drawn with horse blood, mixed, and stood for 30 minutes.They were then centrifuged at 1300g for 10 minutes, using an mse mistral 1000 centrifuge.All samples separated as expected with complete impervious gel barriers.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 has been confirmed for the indicated failure mode poor barrier separation based on photos only.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Customer recommendations: sst¿ tubes should be filled to stated draw volume and mixed by 5 complete inversions.Mixing facilitates dispersion of the silica into the blood, assisting the clotting process.The recommended 30-minute minimum clotting time for the bd sst¿ tube is based upon an intact clotting process.Insufficient clotting (short clotting) can result in the formation of fibrin.This fibrin formation may interfere with barrier formation.Complete and adequate barrier formation is time, temperature and g-force dependent.Post centrifugation: the specimen in the original tube should be centrifuged once.Tubes should not be re-centrifuged once the barrier is formed.A potential for inaccurate test results is possible.Analytes from cellular leakage/exchange, accentuated by clot retraction, will then be centrifuged into the serum being used for testing.If re-centrifugation is required for improved serum quality, then aspirate serum into a properly labeled clean tube.Attached is our ¿tech talk¿ on sst processing to assist in mitigating sample quality issues.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes a problem with gel migration in green tubes and once on dry tubes.Asks if this is due to the density of the serum.The following information was provided by the initial reporter.The customer stated: ¿would like to contact you about a problem with gel migration in green tubes and once on dry tubes.Asks if this is due to the density of the serum.Consequences: re-collected patient and significant consequences on the proper functioning of biochemistry equipment: sample collection needle blocked by gel.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14880655
• Report Number: 9617032-2022-00600
• Device Sequence Number: 17480736
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 05/31/2023
• Device Model Number: 366882
• Device Catalogue Number: 368498
• Device Lot Number: 1330507
• 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: 06/09/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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