MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

Catalog Number	309703
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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 bd syringe 5ml ll tip bulk convenience pak had foreign matter it was reported by customer that black particles found on syringe - particulate under the plunger.Verbatim: rcc received a complaint via email.(b)(4).Defect material description: syringe tray, 5ml bd 25pk (ref.309703) lot number: 5245945 item code: 309703 defective quantity: (b)(4) defect description: black particles found on syringe - particulate under the plunger.Observed date: (b)(6) 2025 observed during which process stage: ilp ir/ dmi number if launched: - sample availability for supplier to investigate: no is defective evidence (i.E.Pictures; test results etc.) available? yes is patient impacted? no if defect has been reported to third party? no if the defect report from quva customer? no is there a trend observed? no supplier action awareness/ attention.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photos.Analysis of the photos showed that in 3 of the photos black marks on the outside of the barrel non-fluid path can be observed.The other 2 photos show magnification of the particulate at 75x and 300x.External ftir analysis was performed and identified the particulate most likely came from the rubber stopper.Bd determined that the cause of the failure was associated with the assembly process.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24234622
• Report Number: 9610847-2026-00041
• Device Sequence Number: 10229990
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037(10)5245945
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/17/2026

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: 309703
• Device Lot Number: 5245945
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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