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

Catalog Number 367528

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

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 before use of the bd vacutainer® brand sst ii tubes containing silica and gel the consumer experienced blood leakage with a defective tube.The consumer stated ¿during blood collection, blood stopped to came in at the first tube.Then it leaked from the side of the shield.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for blood leakage with the incident lot was observed.Additionally, evaluation of the customer samples was performed and blood leakage 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-conformances during manufacturing of the product.Based on evaluation of the customer photos, the customer¿s indicated failure mode for blood leakage with the incident lot was observed.Additionally, evaluation of the customer samples was conducted and blood leakage was not observed.The most likely root cause was poor line clearance by the stopper manufacturer; excess rubber had gone into this stopper leaving it deformed and unable to hold a complete vacuum and or a proper seal against leakage.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 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
• MDR Report Key: 7383104
• MDR Text Key: 104040776
• Report Number: 9617032-2018-00073
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K023331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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
• Device Operator: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 367528
• Device Lot Number: 7191892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other