MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) See H11; Tubes, vacuum sample, with anticoagulant

Catalog Number	367960
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while applying the patient¿s barcode label onto the bd vacutainer® pst¿ gel and lithium heparinn (lh) 56 units blood collection tubes, the stopper of one (1) tube fell off, spilling the blood and requiring recollection.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D.1.Medical device brand name: bd vacutainer® pst¿ gel and lithium heparinn (lh) 56 units blood collection tubes.There were multiple medical device types reported to be involved.The information for the additional device type is as follows.D.2.A medical device type: jka.D.2.B common device name: tubes, vials, systems, serum separators, blood collection.There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k945952;k954592.E.1.Initial reporter facility name: (b)(6).Investigation summary: bd received 1 photo for investigation.The photo was evaluated and shows a person holding a tube with the hemogard closure assembly off of the tube and blood on the counter beneath the tube.The photo does show the customer's indicated failure mode.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.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: See H11
• 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 ; +1(201)847-5186
• MDR Report Key: 50842472
• Report Number: 1917413-2026-00888
• Device Sequence Number: 10278390
• Product Code: GIM
• UDI-Device Identifier: 30382903679608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 367960
• Device Lot Number: 6013804
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• 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