MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367880
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes exhibited erroneous results.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: bd had received samples from the customer facility for evaluation.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 had reached out to the customer and provided troubleshooting related to the issue they were observing.It was determined that the most probable scenario for their issue was that the lithium in the lithium heparin tubes was impacting the cell yield, viability, and performance due to the fact lithium can affect pbmc.The effect is more pronounced with blood aging in the tube and higher lithium concentrations.Bd has recommended that the customer use the bd cell preparation tubes (catalog 362753) for single tube separation of pbmc and for further downstream analysis.The customer acknowledged this information and the issue has been resolved.Therefore, no further evaluation of the customer samples was deemed necessary.Investigation conclusion: bd had reached out to the customer and provided troubleshooting related to the issue.The most likely root cause of the issue has been determined.At this time no further evaluation of the customer samples will be conducted.Root cause description: based on the investigation, the most likely root cause was determined to be that the lithium in the lithium heparin tubes was impacting the cell yield, viability, and performance due to the fact lithium can affect pbmc.
Event or Problem Description
It was reported that bd vacutainer® lithium heparin (lh) 158 usp units blood collection tubes exhibited erroneous results.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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 had reached out to the customer and provided troubleshooting related to the issue they were observing.It was determined that the most probable scenario for their issue was that the lithium in the lithium heparin tubes was impacting the cell yield, viability, and performance due to the fact lithium can affect pbmc.The effect is more pronounced with blood aging in the tube and higher lithium concentrations.Bd has recommended that the customer use the bd cell preparation tubes (catalog 362753) for single tube separation of pbmc and for further downstream analysis.The customer acknowledged this information and the issue has been resolved.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes exhibited erroneous results.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7723720
• Report Number: 1917413-2018-03115
• Device Sequence Number: 16541310
• Product Code: JKA
• UDI-Device Identifier: 50382903678803
• UDI-Public: 50382903678803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 367880
• Device Lot Number: 7340932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 07/05/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 12/26/2018; 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other