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

Model Number 367856

Device Problem Overfill (2404)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no customer samples or photos were returned by the customer in support of this complaint.Therefore, 10 production lot in-house retention tubes samples were draw tested and the issue of overfill was not observed as all tubes were within specification limits.Bd was unable to confirm and/or duplicate the customer¿s indicated failure mode because no samples were returned to be tested and the defect was not observed in the retention testing.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.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes pressure was too high, which ended up with an overfilled tube.The following information was provided by the initial reporter.The customer stated: ¿when the nurse collected blood samples for patients according to the doctor's advice, the vacuum blood collection vessel was used for collection, the pressure in the tube was high, the blood collection needle was pushed out by the pressure, and the blood could not enter the blood collection vessel after the blood collection needle was inserted into the purple bottle cap again.Immediately, a new blood vessel was replaced and blood samples were collected again, and the collection was successful.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15799393
• MDR Text Key: 305065401
• Report Number: 1917413-2022-00720
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678568
• UDI-Public: 50382903678568
• 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: 11/03/2022

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 Expiration Date: 04/30/2023
• Device Model Number: 367856
• Device Catalogue Number: 367856
• Device Lot Number: 1350331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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