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

Catalog Number	309680
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
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 customer that are seeing here at our facility as excess silicone (droplets or globs) in unfilled units prior to use.The silicone is presenting as though there is material or what we would call ¿particulate¿ stuck on the syringe stopper.This is identified through our visual inspection program.Because we are unable to decipher real time if these are silicone, these units are required to be rejected in our process and evaluated by our internal chemistry lab.Verbatim: complaint via email.Email(s) attached.I wanted to share some examples of what we are seeing here at our facility as excess silicone (droplets or globs) in unfilled units prior to use.Please see the attached document (areas of concern are circled in red with descriptions below each picture).These examples are from an unfilled bd 50ml syringe lot 6005434.I am hoping you can help me with the below questions: do you perform visual inspection on all units after manufacturing? if so, is excess silicone something your team looks for during your visual inspection process? what are the requirements for silicone? would these syringes meet your specifications and are deemed as acceptable? the reason i am asking is because after we fill units with the attached examples, the silicone is presenting as though there is material or what we would call ¿particulate¿ stuck on the syringe stopper.This is identified through our visual inspection program.Because we are unable to decipher real time if these are silicone, these units are required to be rejected in our process and evaluated by our internal chemistry lab.We understand lubricant is needed for the functionality of the syringe; however, we are looking to see if there is any additional information you can provide us on how you control this during you manufacturing process and inspection process.Anything information would be greatly appreciated.".

• 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: 25186926
• Report Number: 9610847-2026-00210
• Device Sequence Number: 13425064
• Product Code: FMF
• UDI-Device Identifier: 00382903096800
• UDI-Public: (01)00382903096800(10)6005434
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/10/2026

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: 309680
• Device Lot Number: 6005434
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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