MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. LUER-LOK; SYRINGE

Catalog Number	305617
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
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 by the customer that during the characterization, it traced back to a material, a particle was consistent with polysome and butadiene.They used in total 80 syringes (8 packs of 10), they only discovered it in 2 of them but don't know the lot number of the specific ones with that particle.Verbatim: complaint via phone.Case description: the syringe was used for a reconstitution, a procedure they perform.During the characterization, it traced back to a material, a particle was consistent with polysome and butadiene.They used in total 80 syringes (8 packs of 10), they only discovered it in 2 of them but don't know the lot number of the specific ones with that particle.The customer called to know what's the composition of the syringe and was transferred to med info, where they reached the engineering team and are gonna contact her with the information.Additional information received on 5-jun-2026: 1.Can you please provide an exact date of event in format dd-mmm-yyyy? the particulate was characterized (ftir) and reported on (b)(6) 2026 as consistent with polystyrene possibly with a small amount of butadiene.2.Can you share any physical sample or photo if available for investigation? 3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Because lyophilized cakes can obscure visible particulate matter, there is a risk that particulates may not be detected during routine 100% inspection.If a unit containing particulate matter were administered to a patient, this could result in exposure to extraneous material and present a potential safety risk.In addition, if the batch is rejected or discarded due to confirmed particulate findings not attributable to the reconstitution process, this could adversely affect product availability and may negatively impact the ability to support patient treatment needs in a timely manner.".

• Brand Name: LUER-LOK
• 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: 25535312
• Report Number: 9610847-2026-00251
• Device Sequence Number: 9359019
• Product Code: FMF
• UDI-Device Identifier: 00382903056170
• UDI-Public: (01)00382903056170
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/20/2026

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: 305617
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/20/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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