MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2EDTA TUBE; BLOOD COLLECTION TUBE

Catalog Number 367862

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event unknown.The date received by manufacturer has been used for this field.Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for misapplied additive with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd was able to confirm the customer's indicated failure mode larger droplets of the solution in close proximity to one another then tend to coalesce, and once the water is dried, leave behind a wafer like deposit of the additive.This additive deposit visually stands out as it does not appear like the typical dot pattern for this tube type.

Event Description

It was reported that additive was erroneously applied to the walls of the bd vacutainer® k2edta tube.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® K2EDTA 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: 7100304
• MDR Text Key: 94804515
• Report Number: 1917413-2017-00536
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678624
• UDI-Public: 00382903678624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981013
• 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: 11/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 367862
• Device Lot Number: 6090982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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