MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367957

Device Problems Incorrect Measurement (1383); Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® sst¿ ii advance plus blood collection tubes there was a clogged/blocked instrumentation probe and oil gel globules.The following information was provided by the initial reporter.The customer stated: there are "numerous problems with the sst tubes after centrifugation, the gel remains in suspension and it clogs our automats.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/18/2021.H.6.Investigation: bd received 37 samples for investigation.The returned samples along with retention samples (from bd inventory of the same lot) were evaluated and the indicated failure mode for gel globules with the incident lot was not observed.4 returned tubes and 4 retained samples were drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1211g for 10 minutes, using an mse mistral 1000 centrifuge.The supernatants were then decanted and examined under magnification for any signs of gel particles or globules; none were found.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 is unable to be confirmed based on the testing of the return and retains samples.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes there was a clogged/blocked instrumentation probe and oil gel globules.The following information was provided by the initial reporter.The customer stated: there are "numerous problems with the sst tubes after centrifugation, the gel remains in suspension and it clogs our automats.".

• Brand Name: BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 12013579
• MDR Text Key: 260593636
• Report Number: 9617032-2021-00630
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 1029743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1