MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP; BLOOD COLLECTION TUBE

Catalog Number	366664
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.(b)(6).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 with the use of the bd vacutainer® lithium heparin (lh) 37 usp units blood collection tubes there was an issue with a difficult erroneous results.It was stated ¿negative bias with ionized calcium.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: 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 with the use of the bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes there was an issue with a difficult erroneous results.It was stated ¿negative bias with ionized calcium.¿ there was no report of injury or further medical intervention.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7631093
• Report Number: 1917413-2018-03035
• Device Sequence Number: 19262135
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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 Catalogue Number: 366664
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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