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

Catalog Number	365044
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion: bd has initiated a capa (b)(4) to document further investigation and root cause(s) of this product issue.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 sometimes the green bd vacutainer® barricor¿ plasma blood collection tubes has blood squirt out of them when the tube is pulled away after filling it.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
The initial mdr was submitted without a 510k number but this device does have a 510k associated with it.

• Brand Name: BD VACUTAINER® BARRICOR¿ PLASMA BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7097897
• Report Number: 9617032-2017-00479
• Device Sequence Number: 1298041
• 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,Followup
• Report Date (Section B): 01/22/2018

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: 365044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/23/2018
• 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