MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SSTTM II TUBE WITH HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number	366882
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the cap of a bd vacutainer® ssttm ii tube with hemogard¿ closure popped off during centrifugation.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: 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 gel airbubbles with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the customer's indicated failure modes for gel smearing and decapping were not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for gel airbubbles with the incident lot was observed.Additionally, evaluation/testing of the retain samples was conducted and gel smearing and decapping were not observed.Root cause description: based on the investigation, the true root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® SSTTM II TUBE WITH HEMOGARD¿ CLOSURE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7210504
• Report Number: 9617032-2018-00007
• Device Sequence Number: 1158844
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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 Expiration Date: 12/31/2017
• Device Catalogue Number: 366882
• Device Lot Number: 6354942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 03/13/2018
• 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