MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN; LYMPHOCYTE SEPARATION MEDIUM

Catalog Number 362753

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

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

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 that the bd vacutainer® cpt¿ cell preparation tube with sodium heparin had erroneous results from a "10 fold decrease in yield" compared to the "tube processed with ficoll", resulting in a delay of treatment to the patient, who then had to be redrawn at a later, undisclosed date.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa#1092363.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: further investigation has been initiated through capa#1092363.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: capa#1092363 has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

Event Description

It was reported that the bd vacutainer® cpt¿ cell preparation tube with sodium heparin had erroneous results from a "10 fold decrease in yield" compared to the "tube processed with ficoll", resulting in a delay of treatment to the patient, who then had to be redrawn at a later, undisclosed date.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
• Type of Device: LYMPHOCYTE SEPARATION MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8257387
• MDR Text Key: 133461548
• Report Number: 1917413-2019-00005
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627535
• UDI-Public: 50382903627535
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 362753
• Device Lot Number: 8213831
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention