MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364305

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem Alteration In Body Temperature (2682)

Event Date 07/20/2020

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 during use the bd vacutainer® blood collection tubes buffered sodium citrate 0.3 ml - 0.109 m had under-fill or low draw of a tube with blood.This event occurred 6 times.The following information was provided by the initial reporter: the customer stated ¿the tube didn't draw enough sample material.Repeated collection was necessary, extension of the waiting time for the result.¿.

Event Description

It was reported during use the bd vacutainer® blood collection tubes buffered sodium citrate 0.3ml - 0.109m had under-fill or low draw of a tube with blood.This event occurred 6 times.The following information was provided by the initial reporter: the customer stated ¿the tube didn't draw enough sample material.Repeated collection was necessary, extension of the waiting time for the result.¿.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer for evaluation.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 non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M
• 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: 10385741
• MDR Text Key: 204960816
• Report Number: 9617032-2020-00628
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643054
• UDI-Public: 50382903643054
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Model Number: 364305
• Device Catalogue Number: 364305
• Device Lot Number: 9025680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other