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	01/14/2026
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 bd 20ml syringe lot 5181420, ir spectrum demonstrated a 79.2 match to silicone lubricant and, when compared to the broader ftir library, a 93.7 match to silastic q7 4550, a peroxide cured medical grade silicone elastomer consistent with stopper construction.Rcc received a complaint via email.Dmr # (b)(4) po #: (b)(4) defect material description: syringe tray, 20ml bd 10pk (ref.305617) lot number: 5181420 item code: 305617 defective quantities: 1 defect description: bd 20ml syringe lot 5181420, ir spectrum demonstrated a 79.2 match to silicone lubricant and, when compared to the broader ftir library, a 93.7 match to silastic q7 4550, a peroxide cured medical grade silicone elastomer consistent with stopper construction.No units are available to be returned.Observed date: (b)(6) 2026 observed during which process stage: ilp ir/ dmi number if launched: dev-04209 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".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photos.Analysis of the sample showed that at magnification, a particle can be seen.One photo at 75x and the other photo shows the particle at 300x.However, bd cannot confirm the cause of the failure since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.

• 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: 24597965
• Report Number: 9610847-2026-00100
• Device Sequence Number: 18532144
• 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): 05/04/2026

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: 02/26/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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