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

Catalog Number 367955

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/09/2018

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 that after use of the bd vacutainer® brand sst ii advance tubes containing silica and gel a reddish clump broke out of serum through the gel after centrifugation.

Event Description

It was reported that after use of the bd vacutainer® brand sst ii advance tubes containing silica and gel a reddish clump broke out of serum through the gel after centrifugation.

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 poor gel barrier separation with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation & testing and upon completion, all samples separated as expected with complete impervious gel barriers.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for poor gel barrier separation with the incident lot was observed.Additionally, evaluation/testing of the retain samples was conducted and no issues were observed relating to the quality and performance of the gel barrier.Root cause description: based on the investigation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® BRAND SST II ADVANCE TUBES CONTAINING SILICA AND GEL
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 8207035
• MDR Text Key: 131763405
• Report Number: 9617032-2018-03251
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 367955
• Device Lot Number: 8162882
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other