MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 20ML LL S/C 50; PISTON SYRINGE

Catalog Number	303310
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 20ml ll s/c 50 had foreign matter.The following information was provided by the initial reporter: material#: 303310, batch#: 4044308 & 4023256.Verbatim: rcc received a complaint via email.We have an issue with product #303310 (sterile luer-lok 20 ml syringes), lot #4044308.Every syringe has had particulate in it, with particulate not seen in some cases until the final sterile product is evaluated.One of the syringes we opened is melted on the top and is completely missing the luer-lok tip.I have a sample of a syringe with particulate and the melted syringe.I am very concerned that particulate products could be administered to patients if the lot is not recalled.We are also experiencing particulate issues with lot #4023256 to a lesser degree.Additional information provided: please confirm did the particulate present in fluid or non-fluid path.A.In fluid path for the products in lot 4044308 and 4023256.
Additional Manufacturer Narrative
(b)(4) follow up report for correction and device evaluation: based on investigation results, this complaint is no longer reportable.The reported foreign matter was silicone which is part of the manufacturing process, and the amount of silicone found was within specification.One sample for lot number 4023256 and six samples for lot number 4044308 were received by our quality team for evaluation.The samples were visual inspected and it was verified that one sample had an incomplete cylinder defect and one sample had liquid in the fluid pathway.The reported incidents could be verified.A review of the internal manufacturing device records for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, the following root causes were determined: 1.The sample with the incomplete cylinder defect occurred due to an issue with the injection molding process during manufacturing.Actions have been put in place to mitigate this defect.2.For the sample with the liquid in the fluid pathway, the liquid was tested to determine what the substance was and the results came back as silicone.Silicone is a medical-grade lubricant and a component in the product's manufacturing process.Lubricant presence testing was also completed and the amount of silicone found was within specification.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Based on investigation results, the reported foreign matter was silicone which is part of the manufacturing process, and the amount of silicone found was within specification.

• Brand Name: BD SYRINGE 20ML LL S/C 50
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21814761
• Report Number: 9614033-2025-00026
• Device Sequence Number: 7531377
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(11)240325(17)290131(10)4023256
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 303310
• Device Lot Number: 4023256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown