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

Catalog Number	309657
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll 200 s/c barrel cracked.Complaint via email.Incident or problem information.Alberta mdip reference number (id) (b)(4).Date of incident (yyyy-mm-dd): on (b)(6) 2026.Type of incident/problem a1.Defect (observed prior to use).Level of harm hazard.Alberta optional report to cmdsnet (health canada).Incident details nurse was injecting sw into the cathflo vial to reconstitute the medication.When the nurse depressed the plunger, sw sprayed out from the side of the syringe.Upon inspection of the syringe, a crack approximately 1 inch in length noted length wise on the syringe.As there was some sw in the vial, but some had also sprayed out, nurse was unsure exactly how much was in the vial, and the vial of cathflo had to be wasted.Device information.Device name/description syringe luer lock tip 3ml.Manufacture becton dickinson canada inc.Manufacturer code/model 309657.Serial or lot number unknown.Supplier (b)(4), supplier/catalogue number 308-309657.Is the device retained? yes.Number of devices 1.Wiped, contained, labelled? device was clean or not used.Investigation request.Expected type of investigation: actual device tested.E-mail address for person holding device.Site shipping address.Clinical contact information.Primary clinical contact (cc on final report).Manager (cc on final report).Mdip filing reference id (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 25069301
• Report Number: 1213809-2026-00233
• Device Sequence Number: 10738487
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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