MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	367962
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	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient 1 of 2: it was reported while using bd vacutainer® pst¿ gel and lithium heparinn 83 units, erroneous elevated troponin results were reported on one patient.The second sample in the series was normal.Additionally, after re-centrifuging the original sample, normal results were obtained.Fibrin and poor barrier separation were also reported.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.Complaints for sample quality are under statistical control for the month of may 2026.At this time, further testing is not indicated.Additionally, further clinical testing could not be performed as the type of the reported erroneous analyte and material lot number were not provided.Troponin type and material lot number are required to perform clinical testing.Based on a review of the device history record (dhr) 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.The dhr could not be reviewed for the unknown lot number.This complaint is unable to be confirmed for the indicated failure modes.Fibrin, poor barrier separation, and erroneous results.Bd was not able to identify a root cause for the indicated failure mode.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.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 25549043
• Report Number: 1917413-2026-00549
• Device Sequence Number: 13452500
• Product Code: GIM
• UDI-Device Identifier: 30382903679622
• UDI-Public: (01)30382903679622
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K252040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: 367962
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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