MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367986

Device Problem Leak/Splash (1354)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported after drawing blood using the bd vacutainer® sst¿ blood collection tubes, the tube caps were falling off during transportation, which resulted in blood leakage and biological contamination with blood.This event occurred with an unspecified amount of tubes.Sample recollection occurred.There was no report of user impact.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 3201199.D.4.Medical device expiration date: 31-jul-2024.H.4.Device manufacture date: 01-aug-2023.E.1.Initial reporter addr 1:(b)(6).H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19174569
• MDR Text Key: 341613391
• Report Number: 1024879-2024-00368
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903679868
• UDI-Public: (01)30382903679868
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367986
• Device Lot Number: 3257993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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