MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE; BLOOD COLLECTION TUBE

Catalog Number 363083

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Contamination (1120)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.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 that the stopper had fallen off on several occasions 13 x 75 mm, 2.7 ml bd vacutainer® plus plastic citrate tube.The tube was in a lab with other blood samples and contaminated the entire contents of the bag.No injury or medical intervention was reported.

• Brand Name: 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE
• 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: 7059047
• MDR Text Key: 93479325
• Report Number: 1917413-2017-00219
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630832
• UDI-Public: 50382903630832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013971
• 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: 10/30/2017

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 Catalogue Number: 363083
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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