MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH 102 I.U. PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367885

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported when using the bd vacutainer® lh 102 i.U.Plus blood collection tubes have false troponin level results.The following information was provided by the initial reporter.The customer stated: our troponin false results have escalated again! please could we put some dates in the diary to do the training i don't think i can wait for the departments to get back to me as this is more urgent now.

Manufacturer Narrative

The following fields were updated: d9.Device available for evaluation? yes returned to manufacturer on: 21-sep-2023.H.6 investigation summary: material #: 367885.Lot/batch #: 2350881.Bd received 1000 samples for investigation.10 customer samples were randomly selected for functional testing and no issues relating to erroneous results were observed.Clinical testing was performed on additional returned samples.There were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure mode (erroneous results-troponin t) because the defect was not evident in the testing of the complaint lot samples.Replicates of both customer returned and control samples were acceptable in terms of both precision and accuracy.All visual observations of both customer returned and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode erroneous results-troponin t.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.

Event Description

It was reported when using the bd vacutainer® lh 102 i.U.Plus blood collection tubes have false troponin level results.The following information was provided by the initial reporter.The customer stated: our troponin false results have escalated again! please could we put some dates in the diary to do the training i don¿t think i can wait for the departments to get back to me as this is more urgent now.

• Brand Name: BD VACUTAINER® LH 102 I.U. PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17873141
• MDR Text Key: 324960079
• Report Number: 9617032-2023-01310
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Operator: Other
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 367885
• Device Lot Number: 2350881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1