MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368856

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/24/2023

Event Type  malfunction  

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 3261577; d.4.Medical device expiration date: 31-jan-2025; h.4.Device manufacture date: 18-sep-2023.D.4.Medical device lot #: 3261573; d.4.Medical device expiration date: 31-jan-2025; h.4.Device manufacture date: 18-sep-2023.D.4.Medical device lot #: 3180420; d.4.Medical device expiration date: 31-oct-2024; h.4.Device manufacture date: 29-jun-2023.D.4.Medical device lot #: 3191575; d.4.Medical device expiration date: 30-nov-2024; h.4.Device manufacture date: 10-jul-2023.

Event Description

It was reported when using the bd vacutainer® k3e plus blood collection tubes had molding defects which affected the results.There was no report of impact to patient or user.

Event Description

It was reported when using the bd vacutainer® k3e plus blood collection tubes had molding defects which affected the results.There was no report of impact to patient or user.

Manufacturer Narrative

H.6.Investigation summary: bd received 1 photograph from the customer in support of this investigation.Evaluation of the attached photograph showed tubes with a bit of plastic scraped inside.100 retained samples from each lot number provided were visually inspected, and no damaged tubes were found.Bd was able to confirm the customer¿s indicated failure mode with the photograph 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.

• Brand Name: BD VACUTAINER® K3E 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: 18367307
• MDR Text Key: 331018507
• Report Number: 9617032-2023-01833
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903688563
• UDI-Public: (01)30382903688563
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368856
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/14/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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