MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES

Catalog Number	368660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd vacutainer¿ venous blood collection serum silicone-coated plastic tube with conventional stopper was found broken at collection site.There was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation 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 glass breakage with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product.Based on evaluation of the customer photos, the customer¿s indicated failure mode for glass breakage with the incident lot was observed.Based on the investigation, a root cause could not be determined.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¿ VENOUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7369818
• Report Number: 1917413-2018-00088
• Device Sequence Number: 1373177
• Product Code: JKA
• UDI-Device Identifier: 50382903686600
• UDI-Public: 50382903686600
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K091292
• 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,Followup
• Report Date (Section B): 04/26/2018

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: 01/31/2019
• Device Catalogue Number: 368660
• Device Lot Number: 7214731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/26/2018
• 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