MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTRY URINE TESTING; URINE COLLECTION SET

Catalog Number 364990

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5295510.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported with the 10.0 ml 16x100 mm bd vacutainer® plus plastic transport kit for ua chemistry urine testing that several issues with the stopper occurred.This includes: the stopper being half way off before use, stopper couldn't go on completely, transferring urine would not fill the new tube completely.Spills also resulted from needles being stuck in the transfer device.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted with the 510k number listed as k790366.It is corrected to read exempt.

• Brand Name: BD VACUTAINER® PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTRY URINE TESTING
• Type of Device: URINE COLLECTION SET
• 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: 7059030
• MDR Text Key: 93479096
• Report Number: 1917413-2017-00216
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 364990
• Device Lot Number: 5295510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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