MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 363095

Device Problem Occlusion Within Device (1423)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Results: 12 unused tubes were returned.One (1) contained the correct amount of additive, 7 had low amounts and 4 were empty.A drawn tube was also returned that contained clots.The retained samples were evaluated and those contained the correct amount of additive.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5280452.Conclusion: evaluation of the returned samples confirmed the reported defect.

Event Description

It was reported that bd vacutainer plus citrate tube 2.7 ml with light blue hemogard closure had a clotting issue with 4 out of 100 tubes and 14 out of 100 tubes in another set.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted without a 510k number but this device does have a 510k associated with it.

• Brand Name: BD VACUTAINER PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7083215
• MDR Text Key: 94945456
• Report Number: 9617032-2017-00526
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903630950
• UDI-Public: 00382903630950
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 363095
• Device Lot Number: 5280452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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
• Patient Outcome(s): Other