MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL EURO 125 S/C; PISTON SYRINGE

Catalog Number	309649
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 5ml ll euro 125 s/c contained visible silicone.Verbatim: it looks like moisture or something else and the pharmacy is not sure to prepare medication with these syringes.The customer said, it seems like moisture, but she don¿t know it.The liquid was seen above the plunger and inside the syringe body.The samples are on the way and will be examined.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation six samples of 10 ml eurographic syringes, part number 309649, were received and evaluated, with two samples each from batches 5072216, 5280258, and 5309031.All samples arrived in unsealed packaging and showed no defects.Silicone was visible on the stoppers, however, there was no evidence of stringing or pooling, indicating that the amount was not excessive and met product specifications.Silicone is an inert, non toxic medical lubricant that is an integral component of disposable syringes, ensuring proper performance in clinical use.This condition does not impact product safety, efficacy, or functionality.Silicone has been used in this application for over 25 years, with more than 30 billion units distributed and no known reports of adverse clinical effects related to unintended silicone delivery.Please refer to the attached silicone quantity guideline for additional details.Furthermore, a device history record review was completed for lot numbers 5072216, 5280258, and 5309031.The review identified no rejected inspections or quality issues during production that could have contributed to the reported condition.

• Brand Name: BD SYRINGE 5ML LL EURO 125 S/C
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24469915
• Report Number: 1213809-2026-00094
• Device Sequence Number: 21397975
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)251105(17)301031(10)5309031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 309649
• Device Lot Number: 5309031
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown