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 11/02/2022

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 tubes, there is clot mass formation in the serum.This event occurred 4000 times.The following information was provided by the initial reporter.The customer stated: ¿clot in serum there is clot mass formation in the serum.The procedure is carried out by paying attention to the preanalytical rules.This problem only has this lot.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-11-09.H.6.Investigation summary: bd received 100 samples and 5 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for red cell hang up was observed.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 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 tubes, there is clot mass formation in the serum.This event occurred 4000 times.The following information was provided by the initial reporter.The customer stated: ¿clot in serum there is clot mass formation in the serum.The procedure is carried out by paying attention to the preanalytical rules.This problem only has this lot.".

• 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: 15838530
• MDR Text Key: 307827332
• Report Number: 9617032-2022-01160
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 2175056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1