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

Catalog Number 367957

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during use of the bd vacutainer® brand sst ii advance tubes containing silica and gel the customer complained that nearly 50 tubes contained serum like jelly.Customer found 40 tubes without additive.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for insufficient additive quantity with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed pertaining to the additive content as all retain samples met specifications.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-conformances during manufacturing of the product.Based on evaluation of the customer samples, the customer¿s indicated failure mode for insufficient additive quantity with the incident lot was observed.Evaluation of the retain samples did not indicate any issues with the additive content.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.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® BRAND SST II ADVANCE TUBES CONTAINING SILICA AND GEL
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7154402
• MDR Text Key: 96344629
• Report Number: 9617032-2017-00641
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 367957
• Device Lot Number: 7097986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other