MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367846

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® edta 2k the cap had a molding defect, thus resulting in the blood leaking out.There was no report of impact to the patient or user.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: bd received 1 photo from the customer in support of this complaint.Evaluation of the attached photo indicated that the stopper had been moulded incorrectly.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the photo provided.Bd was not able to identify the exact root cause for the indicated failure mode.The device history records could not be reviewed because the lot number was not provided.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® EDTA 2K
• 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. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19217268
• MDR Text Key: 341438792
• Report Number: 1917413-2024-00366
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678469
• UDI-Public: (01)50382903678469
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367846
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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