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

Model Number 367955

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)

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

Event Date 11/22/2022

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 tube there was poor barrier separation of the sample, red cell hang up, and missing additive.The following information was provided by the initial reporter.The customer stated: "sub-optimal separation is always present, which forced the batch change in order to avoid equipment problems.Probable reactivity to serological tests for hcv has been ruled out, not attributable to the tubes.Non-optimal separation - after centrifugation of the samples, the serum shows traces of red blood cells and fibrin filaments; probable reactivity to serological tests for hcv.A higher percentage of false positives for hcv was found 27 reactants in october out of 4222 or 0.64%, 4 reagents in september out of 4329 or 0.09%.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was poor barrier separation of the sample, red cell hang up, and missing additive.The following information was provided by the initial reporter.The customer stated: "sub-optimal separation is always present, which forced the batch change in order to avoid equipment problems.Probable reactivity to serological tests for hcv has been ruled out, not attributable to the tubes.Non-optimal separation - after centrifugation of the samples, the serum shows traces of red blood cells and fibrin filaments; probable reactivity to serological tests for hcv.A higher percentage of false positives for hcv was found 27 reactants in october out of 4222 or 0.64%, 4 reagents in september out of 4329 or 0.09%.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for red cell hang up was observed, however fibrin and poor barrier separation was not observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for red cell hang up and poor barrier separation was not observed.There were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate the customer¿s indicated failure modes of poor barrier separation and red cell hang up, because the defects were not evident in the testing of the complaint lot samples.However bd is able to duplicate the customer's indicated failure mode of fibrin as fibrin strands were visually present in the retain and control samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance except with respect to fibrin.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 the indicated failure mode red cell hang up and fibrin.This complaint is has not been confirmed for poor barrier separation.Bd was not able to identify a root cause for the indicated failure mode.

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16014691
• MDR Text Key: 308458033
• Report Number: 9617032-2022-01296
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 2125068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1