MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367861

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Thrombus (2101)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for (b)(6) was not observed as all samples met specifications.No issues were identified.

Event Description

It was reported that while using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes there was an increase in clotting and platelet "clumping".

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 7450264
• MDR Text Key: 106399559
• Report Number: 1917413-2018-00955
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678612
• UDI-Public: 50382903678612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• 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: 04/18/2018

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: 06/30/2018
• Device Catalogue Number: 367861
• Device Lot Number: 7034520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• 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