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

Model Number 367955

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was red cell hang up and erroneous results.The red cell hang up event occurred 1000 times.The erroneous result event occurred 1 time.The following information was provided by the initial reporter.The customer stated: "after centrifugation the tube had particles aggregated to the walls of the tube and when they enter the equipment clog it.The fact that the serum is not clean, has given false results".39/nov/2022: new info received from the bd sales rep responsible for this case: "today i was following the morning collections at this client and i verified, that they collect 2 biochemistry tubes for each patient, one of 5ml, reference for complaint and one of pediatric volume.One sst tube, to be processed in their central laboratory in lisbon, the 5ml one, and another tube, to be kept in the setubal laboratory, the pediatric one.It turns out that, in several units collected after centrifugation, the tube under complaint, the 5ml one, shows blood red threads, clearly from an incorrect separation of the sample, which remain floating on the top of the serum, on the surface or even aggregated to the wall of the tube.We are talking about the fact that for the same patient, the same collection, the same professional, the same centrifugation, etc., with all the same conditions, the 5ml tube shows the characteristics described previously and the pediatric tube, a totally clean serum.".

Manufacturer Narrative

H.6.Investigation summary: bd received 9 photos for investigation.The photos were reviewed and red cell hang up and poor serum was observed.Erroneous results cannot be seen based on photographs.A complaint history review was performed and revealed a confirmed complaint trend for certain sample quality issues.Based on the confirmed complaint trend a capa (corrective and preventive action) was initiated.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.Erroneous results were reported but could not be further investigated as details on the specific erroneous results were not provided.In addition, certain assays are excluded from our protocols, therefore we are unable to perform internal testing at this time.This complaint has been confirmed for red cell hang up and poor serum based on the trend identified and the photos provided.A corrective and preventive action was created to address the issue.This complaint is unable to be confirmed for erroneous results.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was red cell hang up and erroneous results.The red cell hang up event occurred 1000 tiimes.The erroneous result event occurred 1 time.The following information was provided by the initial reporter.The customer stated: "after centrifugation the tube had particles aggregated to the walls of the tube and when they enter the equipment clog it.The fact that the serum is not clean, has given false results." 39/nov/2022: new info received from the bd sales rep responsible for this case: "today i was following the morning collections at this client and i verified, that they collect 2 biochemistry tubes for each patient, one of 5ml, reference for complaint and one of pediatric volume.One sst tube, to be processed in their central laboratory in lisbon, the 5ml one, and another tube, to be kept in the setubal laboratory, the pediatric one.It turns out that, in several units collected after centrifugation, the tube under complaint, the 5ml one, shows blood red threads, clearly from an incorrect separation of the sample, which remain floating on the top of the serum, on the surface or even aggregated to the wall of the tube.We are talking about the fact that for the same patient, the same collection, the same professional, the same centrifugation, etc., with all the same conditions, the 5ml tube shows the characteristics described previously and the pediatric tube, a totally clean serum.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: 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: 16014255
• MDR Text Key: 308451681
• Report Number: 9617032-2022-01293
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 2237418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1