MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367839

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0007415, medical device expiration date: 2021-05-31, device manufacture date: 2020-01-07; medical device lot #: 0112585, medical device expiration date: 2021-08-31, device manufacture date: 2020-04-21.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 erroneous results were found while using bd vacutainer® k2e 7.2mg plus blood collection tubes.The following information was provided by the initial reporter: we have been made aware that there have been some anecdotal reports of neutrophil aggregation associated with some lot numbers of bd vacutainers, though the evidence seems to be a little anecdotal at the moment.I understand that this can result in a high immature granulocyte count at first presentation to analysers - which may resolve with warming.Do you have any information on this , whether there is any substance to the reports / ongoing investigation?".

Manufacturer Narrative

H.6.Investigation: bd received 3 photographs were attached, showing clumps of neutrophils through the microscope.40 retained tubes were analyzed for the edta content from and were all within spec limits.Bd was unable to confirm the customer¿s indicated failure mode with the retained samples.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h.10.

Event Description

It was reported that erroneous results were found while using bd vacutainer® k2e 7.2mg plus blood collection tubes.The following information was provided by the initial reporter: we have been made aware that there have been some anecdotal reports of neutrophil aggregation associated with some lot numbers of bd vacutainers, though the evidence seems to be a little anecdotal at the moment.I understand that this can result in a high immature granulocyte count at first presentation to analysers - which may resolve with warming.Do you have any information on this , whether there is any substance to the reports / ongoing investigation?".

• Brand Name: BD VACUTAINER K2E 7.2MG 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: 11113783
• MDR Text Key: 226082427
• Report Number: 9617032-2020-01095
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 367839
• Device Lot Number: 0112585
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1