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 Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record (dhr) review was carried out on all the implicated lot numbers (manufactured on line 1) associated with the recent increase in sample quality complaints being reported on (b)(4) sstii tubes.This review identified, from in-process checks, that on each lot number the correct amount of additive was dispensed into the tubes.A review of the additive mixing records for these lots also confirmed that the additive suspension was manufactured correctly, prior to being dispensed into the tubes.A visual comparison of implicated tubes against the same catalogue number manufactured on a different line indicated a potential difference in the spray height of the additive on the inside of the tube wall, with the implicated tubes having a lower pattern.Clinical evaluation of these two groups of tubes showed that tubes from the suspect manufacturing line were more prone to red cell hang up / ring than tubes assembled on a different line, due to spray pattern observed.A corrective and preventive action (capa) was therefore opened to investigate this phenomenon.This complaint has been confirmed for the indicated failure mode red cell hang up.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was red cell hang up.The following information was provided by the initial reporter.The customer stated: "we are experiencing a problem with the 7ml gel tubes lot: 2237418: presence of clot on the surface when respecting the 30 min preana time before centrifugation.".

• 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: 16018645
• MDR Text Key: 308360160
• Report Number: 9617032-2022-01305
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: MB
• 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
• Report Date: 12/07/2022

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
• 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: 11/24/2022
• Initial Date FDA Received: 12/20/2022
• 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