MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363048

Device Problem Overfill (2404)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tube there was overfill.The following information was provided by the initial reporter.The customer stated: "the blood exceeded the specified line in the tube.There are overfilled tubes with 10% extra filling.".

Event Description

It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tube there was overfill.The following information was provided by the initial reporter.The customer stated: "the blood exceeded the specified line in the tube.There are overfilled tubes with 10% extra filling.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: (b)(6) 2021.Investigation summary: bd received 10 samples from the customer in support of this complaint.Photograph is provided showing acceptable fill level.10 returned and 20 retained samples were draw-tested.From this testing it was determined that all 30 tubes drew within specification.Bd was unable to confirm customers indicated failure mode based on the retained samples test results.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.

• Brand Name: BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11369731
• MDR Text Key: 233341353
• Report Number: 9617032-2021-00172
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630481
• UDI-Public: 50382903630481
• Combination Product (y/n): N
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 363048
• Device Catalogue Number: 363048
• Device Lot Number: 0248535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1