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

Catalog Number	309605
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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 10ml ll tip bulk convenience pak slippery syringe.Verbatim: complaint via phone.Case description: they ordered the product and they noticed it's made of a different material.They stick labels to it usually but the labels are not sticking well on this one because the material is slippery.In case of a confirmed product complaint, they want a replacement.Customer name: x phone number: x email: x facility name: x facility address: x product: 10 ml bd luer-lok syringe pharmacy convenience pak, ref#: 309605, lot#: 5353731 - they have (b)(4) cases, 5328426 - they have (b)(4) full cases.Could you please share the total number of occurrences and the quantity affected for the reported issue, after we proceeded with the replacement request? i cannot provide numbers based on this.We have had several pharmacy technicians complain all syringes (even in different tray) within the lot have the same non-sticking/adhering problem.Numbers were not reported to me, unfortunately.Clarify if slippery substance was noted near the leur or inside the syringe? the slippery feel is on the outside of the syringe.It is the whole entire barrel from the luer lock tip to the flange.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that labels are not adhering adequately to the syringes due to the slippery nature of the barrel surface.To support the investigation, the quality team received eight hundred sixty samples of 10ml luer lok syringes for evaluation.All syringes were received in trays, including seven hundred twenty units from lot 5353731 and one hundred forty units from lot 5328426.No foreign matter was observed on the syringe barrels, however, the barrels exhibited a slippery feel, and labels did not adhere or remain affixed to the outer barrel.This condition is nonconforming to the product specification and appears to be associated with the assembly process.A device history record review was completed for material number 309605, lot 5353731.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the inspection control plan, approved for shipment, and considered compliant with product specification requirements at the time of release.To date, no other similar events have been reported for this lot.Based on the investigation and evaluation of the returned samples, the condition reported by the customer has been confirmed.

• 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: 24911731
• Report Number: 1213809-2026-00202
• Device Sequence Number: 9085781
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 309605
• Device Lot Number: 5353731
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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