MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367986

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0077596, medical device expiration date: 2021-03-31, device manufacture date: (b)(6) 2020.Medical device lot #: 0087047, medical device expiration date: 2021-03-31, device manufacture date: (b)(6) 2020.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd vacutainer® sst¿ blood collection tubes had poor barrier separation.The following information was provided by the initial reporter: "material no.367986, batch no.0077596 and 0087047.It was reported that there was poor barrier separation.(b)(6) : (b)(6) 2020 16:11:02 (gmt) the customer called to report the barrier polymer in the bd vacutainer sst gold 5ml tubes from lots 0077596 and 0087047 is not moving upward enough during centrifugation to properly separate the serum from the fibrin and cells.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1862 rcf for 10 minutes, using an mse mistral 1000 centrifuge.All 4 tubes were found to have good gel separation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint cannot be confirmed.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that bd vacutainer® sst¿ blood collection tubes had poor barrier separation.The following information was provided by the initial reporter: "material no.367986, batch no.0077596 and 0087047.It was reported that there was poor barrier separation.(b)(6): on (b)(6) 2020 16:11:02 (gmt).The customer called to report the barrier polymer in the bd vacutainer sst gold 5ml tubes from lots: 0077596 and 0087047 is not moving upward enough during centrifugation to properly separate the serum from the fibrin and cells.".

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11103427
• MDR Text Key: 226556797
• Report Number: 1024879-2020-00977
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1