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

Model 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	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd vacutainer® serum blood collection tubes elevated ldh values were discovered during an internal clinical study.There was no impact to patients and results were not reported to clinicians.This event occurred 80 times.The following information was provided by the initial reporter.The complaint stated: "in an internal clinical study, (b)(6), it was found that the value for ldh was significantly larger when the tube clotted in an upside down vs right-side up orientation.The ldh issue was not seen in other tubes in the same study that were processed and examined in a similar fashion.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1347901.Medical device expiration date: 31-mar-2023.Device manufacture date: 13-dec-2021.Medical device lot #: 1347902.Medical device expiration date: 31-mar-2023.Device manufacture date: 13-dec-2021.
Additional Manufacturer Narrative
Investigation summary: bd did not receive returned samples or photos from the customer for investigation of erroneous results.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 while using the bd vacutainer® serum blood collection tubes elevated ldh values were discovered during an internal clinical study.There was no impact to patients and results were not reported to clinicians.This event occurred 80 times.The following information was provided by the initial reporter.The complaint stated: "in an internal clinical study, (b)(6), it was found that the value for ldh was significantly larger when the tube clotted in an upside down vs right-side up orientation.The ldh issue was not seen in other tubes in the same study that were processed and examined in a similar fashion.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14292957
• Report Number: 1024879-2022-00261
• Device Sequence Number: 19215462
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: 50382903666688
• 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 Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: SEE H10
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 09/25/2024
• 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 Sex: Unknown