MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366450
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd vacutainer® k3 edta (k3e) 12mg blood collection tubes had dark clumps in the tube which are possibly foreign material.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd vacutainer® k3 edta (k3e) 12mg blood collection tubes had dark clumps in the tube which are possibly foreign material.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
Event or Problem Description
It was reported that bd vacutainer® k3 edta (k3e) 12mg blood collection tubes had dark clumps in the tube which are possibly foreign material.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

• Brand Name: BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7698915
• Report Number: 1917413-2018-03031
• Device Sequence Number: 11424080
• Product Code: JKA
• UDI-Device Identifier: 50382903664509
• UDI-Public: 50382903664509
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2018

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 366450
• Device Lot Number: 7340829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 06/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/01/2018; 09/28/2018
• 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