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

Model Number 367955

Device Problems Component Missing (2306); Device Ingredient or Reagent Problem (2910)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2171047, medical device expiration date: 2023-12-31, device manufacture date: 2022-06-20.Medical device lot #: 2164897, medical device expiration date: 2023-12-31, device manufacture date: 2022-06-13.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was red cell hang up and missing additive.The red cell hang up event occurred 2 times.The missing additive event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "we have noticed a problem with the appearance of the serum in the yellow dry gel tubes - ref.367955.We are obliged to recentrifuged a few minutes after removal of blood clots and filaments.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-12-09.H.6.Investigation summary: bd received 199 samples for investigation.The samples were not sent for clinical evaluation because the defect was already confirmed on retained samples.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.This complaint has been confirmed for red cell hang up and fibrin based on the trend identified.A corrective and preventive action was created to address the issue.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was red cell hang up and missing additive.The red cell hang up event occurred 2 times.The missing additive event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "we have noticed a problem with the appearance of the serum in the yellow dry gel tubes - ref.367955.We are obliged to recentrifuged a few minutes after removal of blood clots and filaments.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
• 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: 15851968
• MDR Text Key: 307181151
• Report Number: 9617032-2022-01184
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/14/2023

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 Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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