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 367856

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

E.5.Initial reporter phone # (b)(6) there were multiple medical device types reported to be involved.The information for the additional device type is as follows: g.2.Medical device type: gim there were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g5.Pma / 510(k)#: k213670 h.6.Investigation summary: bd had not received samples, but 9 photos were returned by the customer in support of this complaint from catalog 367856, lot number 3194742.Visual examination of the photos was performed and revealed damage to the corner of the shelf carton tray, and the shelf pack label was missing from one of the shelf cartons.Bd was able to confirm the customer¿s indicated failure modes with the investigation completed.The exact cause for the customer¿s failure modes could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.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.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes the photo showed that there was no label on the shelf pack.There was no report of impact to the patient or user.

• 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. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19212718
• MDR Text Key: 342009675
• Report Number: 1917413-2024-00363
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903678564
• UDI-Public: (01)30382903678564
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/05/2024

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: 367856
• Device Lot Number: 3194742
• 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
• Date Device Manufactured: 07/13/2023
• 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