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

Catalog Number 367989

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd vacutainer® sst¿ blood collection tube, there was a bur on the bottom of the tube.There was no report of patient impact.

Manufacturer Narrative

E1.(b)(6) hospital.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 16-jan-2024.H.6.Investigation summary: bd received 1 returned sample and 3 photos from the customer for investigation for molding defect.Visual examination of the samples and photos revealed flash on the tubes.Device history record review of reported incident lot determined all product release requirements were met.There were no related quality issues during product manufacture.This complaint has been confirmed for flash.Bd was unable to identify a root cause for indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use with the bd vacutainer® sst¿ blood collection tube, there was a bur on the bottom of the tube.There was no report of patient impact.

• 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: 18540222
• MDR Text Key: 333493224
• Report Number: 1024879-2024-00015
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679893
• UDI-Public: (01)50382903679893
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 367989
• Device Lot Number: 3116893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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