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

Catalog Number	366882
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Bd received 95 samples from the customer facility for investigation.24 samples were evaluated and the customer's indicated failure mode for stopper creepout with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd was unable to duplicate or confirm the customer¿s indicated failure mode with the samples provided.
Event or Problem Description
It was reported that stopper creepout/popoff occurred with the bd vacutainer® sst¿ ii advance tubes during pneumatic transport and while resting on a table.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE TUBES
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7079363
• Report Number: 9617032-2017-00497
• Device Sequence Number: 16423735
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K023331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 01/31/2018
• Device Catalogue Number: 366882
• Device Lot Number: 7020980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 12/04/2017
• 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