MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS PLASTIC PST TUBE HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 367960

Device Problems Detachment Of Device Component (1104); Filling Problem (1233); Suction Problem (2170); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The (b)(4) samples were returned for evaluation.The tubes were tested for their draw and all fell within the specification limits.The samples were also inspected for cocked stoppers.None of the samples had this defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5175973.Bd was not able to duplicate or confirm the customer's indicated failure mode.

Event Description

It was reported that 3.0 ml bd vacutainer® plus plastic pst tube hemogard¿ closure were not filling properly, had caps that were crooked/canted on tubes, no vacuum, and had caps that would come off after filling.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PLUS PLASTIC PST TUBE HEMOGARD¿ CLOSURE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7075710
• MDR Text Key: 94206288
• Report Number: 1917413-2017-00304
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679602
• UDI-Public: 50382903679602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 367960
• Device Lot Number: 5210995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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