MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBE

Catalog Number	365044
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results - bd received 100 samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for blood pooling with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - bd was not able to duplicate or confirm the customers indicated failure mode.
Event or Problem Description
It was reported that blood pooled in the stopper of the bd vacutainer® barricor¿ lithium heparin plasma blood collection tube.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMA BLOOD COLLECTION TUBE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7077974
• Report Number: 9617032-2017-00383
• Device Sequence Number: 1351939
• Product Code: JKA
• UDI-Device Identifier: 50382903650441
• UDI-Public: 50382903650441
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K160657
• 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
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 365044
• Device Lot Number: 6145852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 12/03/2017
• 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