MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK; 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	10/10/2025
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 tip bulk convenience pak had foreign matter.The following information was provided by the initial reporter: material#: 309605, lot#: unknown (potential lot: 4354977, 5211788).Rcc received a complaint via email.During compounding of lot#: 20251014-89a41d the following syringe issues were noticed.1 deformed plunger and barrel - available for return.1 deformed barrel - available for return.Two lot# were used in compounding so i¿m unsure which lot# belongs to the complaint units.Date was on (b)(6) 2025.No patient involvement.On (b)(6) 2025.Pcc-25-137.Sterile syringe tray 10ml.309605 expiry 6/30/2030 and 11/30/2029.Deformed syringe.Plunger and barrel deformed, black ink on inside of barrel.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - foreign matter two samples and two photos of 10 ml luer-lok syringes (part number 309605) were received and evaluated.One syringe showed significant damage to the plunger rod, while the other had a grey, grease-like residue on the barrel, plunger rod, and stopper in the non-fluid path, consistent with manufacturing grease.Additionally, the photos indicated that both syringes contained an unknown clear fluid¿one showing plunger damage and the other showing foreign matter.These conditions are non-conforming to product specifications.The potential root cause for the foreign matter in the non-fluid path is linked to the molding process, while the potential root cause for the plunger rod damage is associated with the assembly process.Furthermore, a device history record review was completed for the provided lot numbers 4354977 and 5211788.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.Our business team regularly reviews the collected data to identify emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
• 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: 23459691
• Report Number: 1213809-2025-00697
• Device Sequence Number: 18743988
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 309605
• Device Lot Number: UNKNOWN
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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