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

Catalog Number	309642
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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 the bd syringe 10ml ll w/ndl 21x1 rb had foreign matter.The following information was provided by the initial reporter: material: 309642 batch#: 5232394.Verbatim: rcc received a complaint via email.Email(s) attached.Customer xxx reported receiving item# bf309642 with black liquid/substance on the top part.Please see attached.Waiting for customer additional information.- purchase order number - quantity purchased - quantity affected would like to report that item bf309642 has a black substance in the needle area.(customer email copy attached with pictures).
Additional Manufacturer Narrative
(b)(4) follow up.It was reported that the syringe exhibited a black liquid substance on the top portion.Because no physical sample was returned, a comprehensive evaluation could not be performed.To support the investigation, the quality team reviewed three photographs of a 10ml luer lok syringe.One photograph shows the variable data on the top web slip, including all applicable product information.The second shows the clear side of the package with the needle shield displaying dark discoloration.The third shows the syringe outside the package with the same discoloration visible on the needle shield.No other defects or imperfections were observed in the images.A device history record review was completed for material number 309642, lot 5232394.The review confirmed that all visual inspections were performed per requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan and subsequently approved for shipment.Additional device histories were reviewed for each lot of needles used in manufacturing this final batch, and no documentation of this type of defect was found during the production run.To date, no other similar events have been reported for this lot.Based on the investigation and the photograph based assessment, the customers reported symptom is confirmed.In the absence of the physical sample, a probable root cause could not be determined.

• Brand Name: BD LUER-LOK PRECISIONGLIDE
• 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: 23816479
• Report Number: 1213809-2025-00784
• Device Sequence Number: 9350382
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 309642
• Device Lot Number: 5232394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown