MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367812

Device Problem Separation Failure (2547)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6) h.6.Investigation summary: bd did not receive samples or photos for review and analysis in support of this complaint.Additionally, 30 retain samples were subjected to a visual inspection for stopper cocked.0 of 30 samples failed.Therefore, bd is unable to confirm the customer reported defect based on retain sample analysis.The device history record was reviewed with no issues being identified.There were no quality notifications.All process and final inspections comply with specification requirements.Based on a review of batch records and the investigation results, no root cause from the manufacturing process has been identified as a contributor to the customer reported defect.Complaints received for this device and reported condition 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 identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes had a stopper that was difficult to remove.This affected 12 tubes.There was no report of patient impact.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• 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: 18984327
• MDR Text Key: 339013640
• Report Number: 1024879-2024-00278
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903678120
• UDI-Public: (01)30382903678120
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367812
• Device Lot Number: 3226525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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