MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH (LITHIUM HEPARIN) 102 I.U. PLUS BLOOD COLLECTION TUBES; EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT

Catalog Number	368886
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Patient 2 of 3.It was reported when using the bd vacutainer® lh (lithium heparin) 102 i.U.Plus blood collection tubes there was a false positive troponin i result on one patient.When the sample was first tested the result was elevated; when the sample was tested again the result was normal.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos 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.This complaint is unable to be confirmed for the indicated failure mode of erroneous results.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Patient 2 of 3: it was reported when using the bd vacutainer® lh (lithium heparin) 102 i.U.Plus blood collection tubes there was a false positive troponin i result on one patient.When the sample was first tested the result was elevated; when the sample was tested again the result was normal.There were no health consequences or impacts reported.

• Brand Name: BD VACUTAINER® LH (LITHIUM HEPARIN) 102 I.U. PLUS BLOOD COLLECTION TUBES
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20758994
• Report Number: 9617032-2024-01831
• Device Sequence Number: 15769059
• Product Code: JKA
• UDI-Device Identifier: 30382903688860
• UDI-Public: (01)30382903688860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 368886
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female