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

Model Number 367815

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that discrepant results were observed on the bd red top tubes and the gold top sst.Verbatim: we ran a small study comparing iron studies between bd red top tubes and the gold top sst on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.

Manufacturer Narrative

The following field has been updated with corrected information: b.5.Describe event or problem: it was reported that discrepant results were observed on the bd vacutainer® serum blood collection tubes.Confirmatory testing was not completed and there was no patient impact.The following information was provided by the initial reporter: we ran a small study comparing iron studies between bd red top tubes on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.H.6.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.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 Description

It was reported that discrepant results were observed on the bd vacutainer® serum blood collection tubes.Confirmatory testing was not completed and there was no patient impact.The following information was provided by the initial reporter: we ran a small study comparing iron studies between bd red top tubes on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16077937
• MDR Text Key: 308368482
• Report Number: 1024879-2022-00747
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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: Health Professional
• Device Model Number: 367815
• Device Catalogue Number: 367815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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