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 Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Initial reporter phone number: (b)(6).

Event Description

It was reported that 1300 bd vacutainer® buffered trisodium citrate plus blood collection tubes overfilled.The following information was provided by the initial reporter: "over fill volume in citrate 2.7 ml tube".

Event Description

It was reported that 1300 bd vacutainer® buffered trisodium citrate plus blood collection tubes overfilled.The following information was provided by the initial reporter: "over fill volume in citrate 2.7 ml tube.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/11/2021.H.6.Investigation: bd received 1 contaminated sample from the customer for investigation.The sample was evaluated by visual examination and the indicated failure mode for overfill with the incident lot was not observed as all product specifications were met.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.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 11103421
• MDR Text Key: 228213406
• Report Number: 9617032-2020-01089
• 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

• 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: 01/11/2021
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1