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

Model Number	366444
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
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 that during use with 4 bd vacutainer® sst¿ ii advance plus blood collection tubes there was a low draw.Recollection was not performed.Patient 5 of 11 the following information was provided by the initial reporter: site has expressed concern that the blood draw is slower than expected and that the total sample volume is inconsistent.This is resulting in quantities of plasma insufficient for the aliquotting required for the protocol.Variable total volume obtained resulted in full allocation of serum aliquots not being able to be completed.Thus, less samples available for analysis than anticipated.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but additionally, twenty (20) retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.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 underfill.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that during use with 4 bd vacutainer® sst¿ ii advance plus blood collection tubes there was a low draw.Recollection was not performed.Patient 5 of 11.The following information was provided by the initial reporter: site has expressed concern that the blood draw is slower than expected and that the total sample volume is inconsistent.This is resulting in quantities of plasma insufficient for the aliquotting required for the protocol.Variable total volume obtained resulted in full allocation of serum aliquots not being able to be completed.Thus, less samples available for analysis than anticipated.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes d9: returned to manufacturer on: 2023-05-10 h.6.Investigation summary: bd received nine (9) samples and one (1) photo for investigation.The photo was reviewed and the indicated failure mode for underfill was observed.Additionally, nine (9) customer returns and twenty (20) retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.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 underfill.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that during use with 4 bd vacutainer® sst¿ ii advance plus blood collection tubes there was a low draw.Recollection was not performed.Patient 5 of 11 the following information was provided by the initial reporter: site has expressed concern that the blood draw is slower than expected and that the total sample volume is inconsistent.This is resulting in quantities of plasma insufficient for the aliquotting required for the protocol.Variable total volume obtained resulted in full allocation of serum aliquots not being able to be completed.Thus, less samples available for analysis than anticipated.

• 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: 16744354
• Report Number: 9617032-2023-00412
• Device Sequence Number: 20514976
• Product Code: JKA
• UDI-Device Identifier: 50382903664448
• UDI-Public: (01)50382903664448
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 05/11/2023

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: 10/31/2023
• Device Model Number: 366444
• Device Catalogue Number: 366444
• Device Lot Number: 2116168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 05/11/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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