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

Model Number	366882
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 when using the bd vacutainer® sst¿ ii advance plus blood collection tubes customer stated that tubes are coated with clot activator and gel at the bottom and up the side of the tubes.There are very 'large' 'lumps' of gel and clot activator on the side of the tubes and 'tongues' of gel up the side.The following information was provided by the initial reporter.The "it concerns the bd ssttm ii advance (serum with gel) tube type and the following lot numbers have been examined, 2203591, 2245739, 2311301, 2283470 and 2175165.Bd's tubes are coated with clot activator and gel at the bottom and up the side of the tubes.There are very 'large' 'lumps' of gel and clot activator on the side of the tubes and 'tongues' of gel up the side.There are is in comparison with other manufacturer's similar tube types not visible spray / lumps of gel and clot activator or 'tongues' of gel.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for gel airbubbles was observed.Additive abnormality, gel smearing, and instrument issues could not be observed from the photos.200 retained samples from the batch: 2311301 were visually inspected and no defects were found for all indicated failures mode: gel air bubbles, additive abnormalities, gel smearing.200 retained samples from the batch: 2175165 were visually inspected and 2 tubes had gel airbubbles.No additive abnormalities or gel smearing were found during the inspection.200 retained samples from the batch: 2203591 were visually inspected and 8 tubes had gel airbubbles.No additive abnormalities or gel smearing were found during the inspection.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 gel air bubbles based on the investigation completed.Bd was unable to confirm this complaint for additive abnormality, instrument issues, or gel smearing.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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes customer stated that tubes are coated with clot activator and gel at the bottom and up the side of the tubes.There are very 'large' 'lumps' of gel and clot activator on the side of the tubes and 'tongues' of gel up the side.The following information was provided by the initial reporter.The "it concerns the bd ssttm ii advance (serum with gel) tube type and the following lot numbers have been examined, 2203591, 2245739, 2311301, 2283470 and 2175165.Bd's tubes are coated with clot activator and gel at the bottom and up the side of the tubes.There are very 'large' 'lumps' of gel and clot activator on the side of the tubes and 'tongues' of gel up the side.There are is in comparison with other manufacturer's similar tube types not visible spray / lumps of gel and clot activator or 'tongues' of gel.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION 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 ; 8448235433
• MDR Report Key: 17121515
• Report Number: 9617032-2023-00707
• Device Sequence Number: 7038737
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 09/13/2023

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: 06/30/2023
• Device Model Number: 366882
• Device Catalogue Number: 366882
• Device Lot Number: 2175165
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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