MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: VACUTAINER PLUS¿ GLASS SERUM TUBE; BLOOD COLLECTION SET

Catalog Number	366431
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a photo was sent that showed the mixing between liquids that should not be mixed.A sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 4219670.Conclusion - the investigation of this complaint confirms the reported condition and being related to the manufacturing process.
Event or Problem Description
It was reported that the bd vacutainer¿ venous blood collection tubes: vacutainer plus¿ glass serum tubes, silicone-coated, with conventional stopper had the liquids mixing together when they are not supposed to.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: VACUTAINER PLUS¿ GLASS SERUM TUBE
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7059125
• Report Number: 1917413-2017-00234
• Device Sequence Number: 19141179
• Product Code: JKA
• UDI-Device Identifier: 00382903664313
• UDI-Public: 00382903664313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 10/31/2017

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: 08/31/2016
• Device Catalogue Number: 366431
• Device Lot Number: 4219670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2015
• Initial Report FDA Received Date: 11/27/2017
• 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