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

Catalog Number	366668
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 that an internal study was conducted using bd vacutainer® serum blood collection tubes which indicated that the orientation of the tube during clotting had a significant effect on the ldh value.Tubes clotted upside down had higher ldh values than tubes clotted right side up.116 tubes were studied.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.Therefore, (b)(4) retention samples from bd inventory were evaluated by visual examination and the issue relating to erroneous results-ldh was not observed.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.As part of the complaint investigation, another clinical study was performed which expanded the scope to all clotting tubes.This study evaluated both minimum and maximum clotting times for both right-side up (rsu) and upside-down (ud) tubes.Results indicated that when clotted upside-down (ud), the smaller volume (2ml) serum tube had an extreme bias of ldh when compared with the same size tube right side up (rsu) for maximum clotting time.For minimum clotting time, tubes when clotted upside-down also exhibited a bias and/or confidence intervals outside of the cal for ldh.The internal study concluded that ldh has shown sensitivity to clotting orientation in most serum tubes.This complaint is confirmed for erroneous results-ldh.Bd has initiated a capa (corrective and preventative action) to formally investigate this issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for monitoring of current trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported that an internal study was conducted using bd vacutainer® serum blood collection tubes which indicated that the orientation of the tube during clotting had a significant effect on the ldh value.Tubes clotted upside down had higher ldh values than tubes clotted right side up.116 tubes were studied.There was no report of patient impact.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Common Device Name: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19133228
• Report Number: 1024879-2024-00347
• Device Sequence Number: 17848924
• Product Code: JKA
• UDI-Device Identifier: 30382903666684
• UDI-Public: (01)30382903666684
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 366668
• Device Lot Number: 3034089
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2023
• 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 Sex: Unknown