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

Catalog Number	305618
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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 the bd syringe 30ml ll tip conv pak had foreign matter.The following information was provided by the initial reporter: material#: 305618.Batch#: 5112150.Verbatim: rcc received a complaint via email.I pulled this email to report once again the same issue we had in the past ((b)(6)2025).One of the 30 cc syringe lot is having this growth like material after filling.It shows cloudiness after filling.In one of the pictures, it's very clear the growth/foreign material is on the top of plunger.We also had a complaint from the customer as well.We have segregated these syringes and kept them for your investigation once again.We would like to put this 30 cc syringe lot 5112150 on hold.I am including my warehouse manager as well in this email so we can see if we have another lot to use.But this is a very urgent matter.30 cc syringe tray (bd).Syringe lot number: 5112150.Exp.Date: 2030-03-31.Qty: (b)(4) and kept increasing as soon as we use.Additional information provided: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Answer: since this syringe was not used for any patient and was caught after filling during visual inspection process.No patient was involved.Can you please provide an exact date of event in format dd-mmm-yyyy? answer: (b)(6) 2025.There were two separate batches from our internal syringe batches.Both involved the same syringe lot 5112150.This lot 5112150 was put on hold and started using next lot 5129092.Total affected syringes so far are 4, which the samples are available for your investigation.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 3 photos and 1 physical sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection and testing of the samples.Analysis of the sample showed that the syringe rubber stopper-plunger rod has at the tip what appears to be silicone lubricant.Ftir testing was not able to reliably determine the foreign material, but based on the similarity of the results it is likely related to or contaminated by a silicone derivative.Bd was not able to determine the cause of the 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.
Event or Problem Description
No additional information.

• Brand Name: LUER-LOK
• Common Device Name: PISTON 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: 23543592
• Report Number: 9610847-2025-00422
• Device Sequence Number: 9609953
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187(17)300331(10)5112150
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/16/2025

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: 305618
• Device Lot Number: 5112150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown