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 (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that they confirmed silicone oil presence associated with the supplied component lot.Rcc received a complaint via email.Dmr # (b)(4) po #: (b)(4) defect material description: syringe tray, 20ml bd 10pk (ref.305617) lot number: 5195502, 5181420, item code: 305617, defective quantity: 2 , defect description: this dmr is initiated to formally notify the syringe supplier of confirmed (b)(4) with the supplied component lot, identified during internal quality investigation.Although no particulate matter was confirmed by ftir analysis or qc visual assessment, the investigation concluded the observed defect was silicone oil.We wish to request for silicon oil addition specification and the safety justification report/data (medical grade/ inert, biocompatible, etc) observed date: (b)(6) 2026 observed during which process stage: ilp ir/ dmi number if launched: (b)(4) 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
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

• 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: 24334275
• Report Number: 9610847-2026-00063
• Device Sequence Number: 9799528
• Product Code: FMF
• UDI-Device Identifier: 00382903056170
• UDI-Public: (01)00382903056170(17)300531(10)5181420
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 5181420
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown