MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309657
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 3ml ll 200 s/c plunger rod was broken/damaged.Complaint via email.Email(s) attached complaint reference #: (b)(4).Complaint reference #: (b)(4).Customer (hospital) name: x customer address: x contact name: x phone: x e-mail: x correspondence language: english cat# of product being complained: bd309657 description of product: syringe ll tip st 3cc (b)(4) /bx 4bx/ca.Lot or s/n: (b)(6).Complaint category: fail to function / defective incident date: 19 mar 2026 hospital complaint reference #: (b)(4).Details of complaint (reported issue): the plunger of this syringe is prone to deformation.Complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no has x been informed? unknown qty affected: (b)(4) ea samples available? no is customer requesting an rga?: no return qty:.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - plunger rod broken/damaged the customer reported deformation of the syringe plunger.To support the investigation, one photo of a 3 ml luer lok syringe (part number 309657) was reviewed by the quality team, showing a fully assembled, loose syringe with a severely bent plunger rod.This condition compromises the functionality and structural integrity of the syringe and is considered non conforming to product specifications, with the potential root cause associated with the assembly process.A device history record review was completed for material number 309657, lot 4362152, and confirmed that all in process and final inspections were performed as required, with no related quality notifications identified.The lot met acceptance criteria, was approved for shipment, and complies with applicable specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24845648
• Report Number: 1213809-2026-00190
• Device Sequence Number: 5663661
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573(17)291130(10)4362152
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: Health Professional
• Device Catalogue Number: 309657
• Device Lot Number: 4362152
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown