MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINE COLLECTION, BULK TUBE; URINE COLLECTION SYSTEM

Catalog Number 364992

Device Problem Component Missing (2306)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A sample was not returned for evaluation.A photo was returned and the reported defect was observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5120615.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 that bd vacutainer® urine collection, bulk tube had no label.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted with the incorrect medical device type.The correct type is kdt.The initial mdr was submitted with a 510k number but this device is exempt and does not have a 510k associated with it.

• Brand Name: BD VACUTAINER® URINE COLLECTION, BULK TUBE
• Type of Device: URINE COLLECTION SYSTEM
• 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: 7116910
• MDR Text Key: 95072376
• Report Number: 1917413-2017-00599
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 00382903649921
• UDI-Public: 00382903649921
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 364992
• Device Lot Number: 5120615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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