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

Model Number	368661
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® k2 edta (k2e) blood collection tube overfilled during use and would not pipette as a result.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we have had several reports from the lab that performs our testing that the greiner tubes are ¿overfilling¿ - babesia tubes have too much volume in them.It affects the equipment when pipetting.The equipment has a sensor and when the levels are higher than they should be, it will not pipette.Some blood must be removed to allow pipetting to occur." "the lab stated they began to see these high volume tubes in january and february.It appears to be occurring sporadically within the lot.Someday the lab received only a handful of high volume tubes, and other days they state they are getting high numbers of them.".
Additional Manufacturer Narrative
The device history records for the sam 300p were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The sam 300p passed ¿out qat from heartsine technologies on the 13th january 2010.The random nature of the events stored in the memory and the 10-minute timeouts, would suggest the device was switching on automatically.Experience has shown that it is reasonable to conclude that these symptoms may be attributed to a membrane failure.The returned sam 300p is now outside of its warranty period and will be scrapped.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9916076
• Report Number: 1917413-2020-00353
• Device Sequence Number: 16958526
• Product Code: JKA
• UDI-Device Identifier: 50382903686617
• UDI-Public: 50382903686617
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 368661
• Device Catalogue Number: 368661
• Device Lot Number: 9280963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other