MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 07/04/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube device experienced poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: (b)(6) 2022 updating material # to 362780 after customer provided lot #.Lot # is not valid with 362753 - is valid with 362780.Bd vacutainer cpt, ref (b)(4) good morning, i recently purchased a pack of bd vacutainer cpt blood collection tubes to be used to isolate mononuclear cells from whole blood as part of a clinical trail at the university of exeter (uk).I attempted this last week, however i was unable to isolate any mononuclear cells.I followed the method published in the pdf on your website, and followed the video published on labtube, both of which state/show that the monocular cells are present in a white layer immediately below the blood plasma.However, in my sample we did not have this layer and i could not extract any monocular cells.

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® cpt¿ mononuclear cell preparation tube device experienced poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: (b)(6) 2022/pw updating material # to 362780 after customer provided lot #.Lot # is not valid with 362753 - is valid with 362780 bd vacutainer cpt, ref 362753 good morning, i recently purchased a pack of bd vacutainer cpt blood collection tubes to be used to isolate mononuclear cells from whole blood as part of a clinical trail at the university of exeter (uk).I attempted this last week, however i was unable to isolate any mononuclear cells.I followed the method published in the pdf on your website, and followed the video published on labtube, both of which state/show that the monocular cells are present in a white layer immediately below the blood plasma.However, in my sample we did not have this layer and i could not extract any monocular cells.

Manufacturer Narrative

H.6.Investigation summary: material #: 362780.Lot/batch #: 2019672.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for poor barrier separation and low yield was not 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 low yield were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure (poor barrier) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples tested demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.The ifu (instructions for use) for this product does not specifically claim a yield of cells rather a percent recovery of the patient's whole blood cell count.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 for the indicated failure mode poor barrier separation and low yield.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to poor barrier separation and low yield were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15152872
• MDR Text Key: 304888915
• Report Number: 1917413-2022-00450
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K891407
• 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: 08/12/2022

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: 01/31/2023
• Device Catalogue Number: 362780
• Device Lot Number: 2019672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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