MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE K3 EDTA

Catalog Number	366401
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
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 before use of the bd vacutainer® venous blood collection tube k3 edta the glass tubes were breaking as they were being filled with blood.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for glass breakage with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the customer's indicated failure mode for glass breakage was not observed as all samples met specifications.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-conformance during manufacturing of the product.Investigation conclusion: based on evaluation of the retention samples and photos, the customer¿s indicated failure mode for glass breakage with the incident lot was not observed as all samples met the required specifications.Additionally, the photos did not identify a specific product issue.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.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 (b)(4) reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE K3 EDTA
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7169251
• Report Number: 1917413-2017-00620
• Device Sequence Number: 1448173
• Product Code: JKA
• UDI-Device Identifier: 50382903664011
• UDI-Public: 50382903664011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• 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
• Report Date (Section B): 03/20/2018

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: 03/31/2019
• Device Catalogue Number: 366401
• Device Lot Number: 7067744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/20/2018
• 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