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

Catalog Number	302995
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation four samples of 10 ml luer lok syringes, part number 302995, were received and evaluated.All samples were received loose with an unidentified cap attached and exhibited a crack in the barrel, located in the non scale marking area, extending through the barrel and resulting in leakage.These observed conditions are nonconforming to product specifications.The potential root cause of the barrel crack and leakage is associated with the assembly process.The lot number was not provided, therefore, a device history record review and quality notification review could not be performed.We appreciate you taking the time to bring this observation to our attention.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
1.What was the impact to the patient or healthcare professional? required a new syringe and additional samples for labs to be pulled.This does require additional disconnect and reconnection of the line, which increased the chances of infection, but none have been noted at this time.2.Any adverse event or serious injury reported to patient or healthcare professional? no.
Event or Problem Description
It was reported that bd syringe 10ml ll s/c 200 had leakage past the stopper.Verbatim: pharmacy has reported four incidents where blood has leaked out the back of the syringe, past the plunger.These syringes are used by pharmacy to prepare heparin 9,000 u/9 ml, which is then sent out for teams to flush hd lines.Additional information received on 26feb2026.The manufacture number for the syringe is 302995.We unfortunately do not have a lot number to provide or even the defective product to return.Teams threw it away before reaching out to us.If we continue to have issues, i have asked teams to retain the syringes for further investigation.I did follow up with the unit that originally submitted the complaint and they advised they do have four syringes that could be shipped back for investigation if we are provided with a shipping label.
Additional Manufacturer Narrative
This report is supplemental to previously submitted 3003152976-2026-00139.The product was originally filed under san agustin but was later determined that the legal manufacturer is canaan.This new mdr is being submitted to correct the legal site and to submit a mdr under the correct site registration number.A correction supplemental was submitted for 3003152976-2026-00139 stating the cancellation of the original mdr.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: 24661086
• Report Number: 1213809-2026-00145
• Device Sequence Number: 9243853
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 302995
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown