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

Model Number 367986

Device Problem Non Reproducible Results (4029)

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

Event Date 01/21/2021

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 when using the bd vacutainer® sst¿ blood collection tubes there was poor barrier separation of sample.The following information was provided by the initial reporter: translated to english.The customer stated: it was reported that there was poor barrier separation and fibrin.We have a thermo fisher sorval st16r.We get 2442 rpm¿s when spinning serum/plasma tubes at 1100 rcf.We have the same braking time as carberry.We have all serum tubes clot for a minimum of 30 minutes.Majority of samples collected in phlebotomy room attached to lab by a variety of technologist¿s, as well as on our ward.".

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes there was poor barrier separation of sample.The following information was provided by the initial reporter: translated to english.The customer stated: it was reported that there was poor barrier separation and fibrin.We have a thermo fisher sorval st16r.We get 2442 rpm¿s when spinning serum/plasma tubes at 1100 rcf.We have the same braking time as carberry.We have all serum tubes clot for a minimum of 30 minutes.Majority of samples collected in phlebotomy room attached to lab by a variety of technologist¿s, as well as on our ward.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 10 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation and fibrin was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to poor barrier separation and fibrin were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure, poor barrier and fibrin, because the defect was not evident in the testing of the complaint lot samples.Visual evaluations of both complaint lot (retains) and control samples demonstrated clinically acceptable performance for all visual observations evaluated.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 has been confirmed for poor barrier separation and fibrin based on the photos provided.H3 other text : see h.10.

• 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: 11467097
• MDR Text Key: 249017110
• Report Number: 1024879-2021-00175
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 0129752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1