MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BRAND SST II ADVANCE TUBES; BLOOD COLLECTION TUBES

Catalog Number 367955

Device Problem Decrease in Suction (1146)

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

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: (b)(4) samples were returned by the customer in support of this complaint, so they were draw tested with deionized water.From this testing it was determined that all (b)(4) tubes drew below specification, between 4.181 and 4.234 ml.(b)(4) photos were also attached showing 2 tubes, 1 containing less blood than the other.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5334791.Conclusion: no definitive root cause could be established for the reported defect.

Event Description

It was reported that bd vacutainer® brand sst ii advance tubes had poor vacuum in tubes causing low draws.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® BRAND SST II ADVANCE TUBES
• Type of Device: BLOOD COLLECTION TUBES
• 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: 7116989
• MDR Text Key: 95073965
• Report Number: 9617032-2017-00590
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K921806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 367955
• Device Lot Number: 5334791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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