MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367878
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	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd received photos from the customer for evaluation.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.Clsi guidelines dictate the cap color, specifically with heparin to be green.
Event or Problem Description
It was reported that during use it is difficult to distinguish between sodium and lithium heparin tubes with a bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes.There was no reported impact to patients.The following information was provided by the initial reporter: (1 of 2 complaints) we utilize both the sodium and the lithium heparin tubes in oncology.We use the sodium heparin for the following tests: flow cytometry only: leukemia/lymphoma phenotyping by multi-color flow cytometry for peripheral blood.Flowcytometry only: leukemia/lymphoma phenotyping by multi-color flow cytometry for bone marrow aspirates.Chromosome analysis - peripheral blood/pubs for constitutional studies.Chromosome analysis - neoplastic (hematological malignancies, leukemia).However, as we also have the lithium tubes on the floor, there have been 2-3 instances in the last two to three weeks where the team has used the incorrect tube, leading to an additional stick or bone marrow aspirate despite messaging to look for the stripes to indicate the sodium heparin and to carefully read the tube label.We feel that ensuring that the tubes look different would help mitigate these errors.

• Brand Name: BD VACUTAINER LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10417759
• Report Number: 1917413-2020-00711
• Device Sequence Number: 3105064
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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 Model Number: 367878
• Device Catalogue Number: 367878
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/17/2020
• 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