MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICORTM TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365053

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd received 1 photograph from the customer in support of this investigation.An evaluation of the photograph indicated a stopper inside the tube without a hemoguard shield.Additionally, 24 retained tubes from the bd inventory were functionally tested and the issue of closure separation was not observed.Bd was able to confirm the customer¿s indicated failure mode from the photograph provided although the issue could not be duplicated within the retention sample testing.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.Information will be captured on trend reports and monitored.

Event Description

It was reported when using the bd vacutainer® barricortm tubes, the device experienced the rubber stopper remaining in the tube.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: inner stopper left behind after de-capping.Tube is filled with patient and transported to the lab.Tube gets decapped on the track, but the inner black cap stays behind.

• Brand Name: BD VACUTAINER® BARRICORTM 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: 15505803
• MDR Text Key: 306264056
• Report Number: 9617032-2022-00956
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 365053
• Device Lot Number: 2165717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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