MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363048

Device Problem Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes experienced overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "when using the reference (b)(4) citrate tube and following the change of the material of the stopper (in particular lot: 0225015 from the orders of september), the citrate tubes are filled much more than before.This can lead to a bad homogenization and pipetting problems by our automatons.".

Event Description

It was reported the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes experienced overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "when using the reference 363048 citrate tube and following the change of the material of the stopper (in particular lot: 0225015 from the orders of september), the citrate tubes are filled much more than before.This can lead to a bad homogenization and pipetting problems by our automatons.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/7/2021.H.6.Investigation: bd received 85 samples from the customer for investigation.20 samples were evaluated by functional testing and the indicated failure mode for overfill with the incident lot was not observed.Additionally, 20 retention samples from bd inventory were evaluated by functional testing and the issue of overfill was not observed.The fill-line on these tubes is a guide to the minimum fill, so the draw should be well above the line until approaching the expiry date.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.

• Brand Name: BD VACUTAINER 9NC 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: 11111442
• MDR Text Key: 228217224
• Report Number: 9617032-2020-01090
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 363048
• Device Catalogue Number: 363048
• Device Lot Number: 0225015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1