MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was poor sample quality and there is a loss of cells able to be recovered.There was no reported patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: experienced user of bd cpt tubes for several different studies, using the same protocol successfully - only with the recently started study with blood collection and pmbc isolation from samples from covid-19 patients, they don´t revover the cell numbers they are used to (approximately 10 million cells) after the first washing step.Same conditions, protocol, centrifuges like in other studies.It is not 100% clear whether they loose the cells during the washing step or whether they don´t harvest the cells from the cpt in the step before.Not clear whether it is a patient specific factor causing this, as cpt performance in the other studies is satisfactory.Hematology analysis of the blood of the covid-19 patients in the study is normal, cell numbers normal.When the pbmcs are isolated from samples from covid-19 patients, the yield is only about 10% of the expected yield.

Manufacturer Narrative

Investigation summary bd had not received samples or photos for investigation.Therefore, 3 retention samples and one control sample from bd inventory were drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1211 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.A complaint history was performed and this was the 1st complaint received for the reported defect on this lot number.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

Event Description

It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was poor sample quality and there is a loss of cells able to be recovered.There was no reported patient impact.The following information was provided by the initial reporter, translated from german to english: experienced user of bd cpt tubes for several different studies, using the same protocol successfully - only with the recently started study with blood collection and pmbc isolation from samples from covid-19 patients, they don´t revover the cell numbers they are used to (approximately 10 million cells) after the first washing step.Same conditions, protocol, centrifuges like in other studies.It is not 100% clear whether they loose the cells during the washing step or whether they don´t harvest the cells from the cpt in the step before.Not clear whether it is a patient specific factor causing this, as cpt performance in the other studies is satisfactory.Hematology analysis of the blood of the covid-19 patients in the study is normal, cell numbers normal.When the pbmcs are isolated from samples from covid-19 patients, the yield is only about 10% of the expected yield.

• Brand Name: BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11090938
• MDR Text Key: 225337342
• Report Number: 1917413-2020-01264
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0232798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1