MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367861

Device Problems Leak/Splash (1354); Premature Separation (4045)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes lids do not close well, they've lost vacuum and caused leakage.The following information was provided by the initial reporter.The customer stated: "the lids do not close well, they have lost vacuum and this causes spillage of the samples.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes lids do not close well, they've lost vacuum and caused leakage.The following information was provided by the initial reporter.The customer stated: "the lids do not close well, they have lost vacuum and this causes spillage of the samples.".

Manufacturer Narrative

H.6.Investigation summary: bd did not receive samples or photos from the customer in support of this complaint.Therefore, 100 retention samples from the bd inventory were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.Furthermore, 10 retention samples were functionally tested and the issue of stopper pop off was not observed as no issues with the hemogard closure assembly being loose or separating during or after the draw testing was completed.Bd was unable to confirm the customer¿s indicated failure mode based on the retention sample analysis.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.Bd was unable to determine a root cause for the reported issue.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG 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: 15859392
• MDR Text Key: 306843563
• Report Number: 1917413-2022-00740
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678612
• UDI-Public: 50382903678612
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 12/05/2022

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: 08/31/2023
• Device Model Number: 367861
• Device Catalogue Number: 367861
• Device Lot Number: 2109080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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