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

Catalog Number	365044
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: 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 blood pooling with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa (b)(4) to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported that different lot numbers of the bd vacutainer® barricor¿ plasma blood collection tube have been tested , and again seeing blood pooling in the stopper cap, though not as much or as often as the previous lot number.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® BARRICOR¿ 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: 7077152
• Report Number: 9617032-2017-00405
• Device Sequence Number: 13704216
• Product Code: JKA
• UDI-Device Identifier: 00382903650446
• UDI-Public: 00382903650446
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 04/30/2018
• Device Catalogue Number: 365044
• Device Lot Number: 6299939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 12/01/2017
• 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