MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH K2E (K2EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365974

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the bd microtainer® tubes with k2e (k2edta) there was an issue with white blood cell count having a positive high result.

Event Description

It was reported with the use of the bd microtainer® tubes with k2e (k2edta) there was an issue with white blood cell count having a positive high result.

Manufacturer Narrative

Investigation summary: retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to white transparent impurities was not observed.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-conformances during manufacturing of the product.Bd received samples and photos from the customer facility for investigation and has initiated further investigation relating to this issue through capa#937863.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for white transparent impurities with the incident lot was not observed as all samples met the required specifications.Samples and pictures provided by the customer regarding the indicated failure mode for white transparent impurities in the blood smear resulting in erroneous wbc count will be further investigated through capa#937863.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: capa#937863 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: 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.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8278950
• MDR Text Key: 134197979
• Report Number: 2618282-2019-00101
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903659741
• UDI-Public: 50382903659741
• Combination Product (y/n): N
• PMA/PMN Number: K991702
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 365974
• Device Lot Number: 8058746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other