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

Catalog Number	365045
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that bd vacutainer® barricor¿ had blood pooling on top of stopper once removed from collection device.No injury or medical intervention reported.
Additional Manufacturer Narrative
The initial mdr was submitted with an incorrect date received by manufacturer.The correct date received by manufacturer is 07/25/2017.

• Brand Name: BD VACUTAINER® BARRICOR¿
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7083766
• Report Number: 9617032-2017-00508
• Device Sequence Number: 11125382
• Product Code: JKA
• UDI-Device Identifier: 50382903650458
• UDI-Public: 50382903650458
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 365045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2015
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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