MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364305

Device Problem Short Fill (1575)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: "bd did not receive samples or photographs from the customer in support of this complaint.The expiry date of the lot number involved was october 2022.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the tubes has expired.Bd was not able to identify a root cause for the indicated failure mode.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.".

Event Description

It was reported when using the bd vacutainer® blood collection tube buffered sodium citrate is underfilling.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: "problem with underfilling and reach up to filling line on the tube.Staff from 1 healthcare center had difficulties to reach up correct blood volume and filling line.".

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16064635
• MDR Text Key: 308525443
• Report Number: 9617032-2022-01335
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K013971
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 364305
• Device Catalogue Number: 364305
• Device Lot Number: 2025312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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