MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	367961
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d2b: jka.D3: common device name: tubes, vials, systems, serum separators, blood collection.There were multiple 510k numbers reported to be involved.The information is as follows: g4: pma/510(k)#: k945952; k954592.Investigation summary: bd received 2 photos for investigation.The photos were visually evaluated and show a tube with the hemogard closure assembly off of the tube.A total of 100 retention samples were visually inspected, with the hemogard closure assembly correctly assembled and placed on the tubes.No cocked stoppers were identified that would cause the hemogard closure assembly to not be applied correctly.Additionally, 10 retention samples underwent functional testing, and all samples passed testing without any issues.No issues with the hemogard closure assembly being loose or separating were observed during or after the functional testing.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure mode: stopper function.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 the identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® pst¿ gel and lithium heparinn 65 units, the stopper of 1 tube came off while applying a label to the tube and the contents spilled.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 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: 25577980
• Report Number: 1917413-2026-00559
• Device Sequence Number: 5214002
• Product Code: GIM
• UDI-Device Identifier: 30382903679615
• UDI-Public: (01)30382903679615(17)270228(10)6047672
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 367961
• Device Lot Number: 6047672
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2026
• 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