MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368499

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2e 5.4mg plus blood collection tubes, that five tubes had plastic molded protrusions inside the tube.The protrusion prevented the instrument from aspirating the sample.There was no report of impact to the patient or user.

Manufacturer Narrative

H.3.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 additional/corrected information: d.1.Device available for eval: yes; d.1 returned to manufacturer on: 05-apr-2024.H.6.Investigation summary: bd received 100 samples and 4 photos from the customer in support of this investigation.Evaluation of photos indicated tube with a bit of plastic scraped inside.Visual evaluation of 100 returned samples did not confirm the reported defect.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.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.Complaints received for this device and reported conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® k2e 5.4mg plus blood collection tubes, that five tubes had plastic molded protrusions inside the tube.The protrusion prevented the instrument from aspirating the sample.There was no report of impact to the patient or user.

• Brand Name: BD VACUTAINER® K2E 5.4MG 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19023951
• MDR Text Key: 339206878
• Report Number: 9617032-2024-00480
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903684992
• UDI-Public: (01)30382903684992
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368499
• Device Lot Number: 3282098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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