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

Catalog Number 306575

Device Problems Loose or Intermittent Connection (1371); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2019

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 that foreign matter occurred before use with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, "the cap is crushed and dirty.".

Manufacturer Narrative

Investigation summary: one sample and two photos were received for evaluation.The sample has the tip cap bent-damaged and dirty.This occurs when the syringe is misplaced in the sterilizer tray.The next tray that goes on top lays on top of the misplaced syringe tip cap inducing the damage and getting the tip cap dirty.The two photos show the syringe with the tip cap defects.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that foreign matter occurred before use with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, "the cap is crushed and dirty.".

• 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; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9434134
• MDR Text Key: 191436927
• Report Number: 1911916-2019-01289
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9080859
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other