MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 21X1 RB; PISTON SYRINGE

Catalog Number	309575
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 21x1 rb had foreign matter.The following information was provided by the initial reporter: material # 309575.Batch # 5083505.Verbatim: rcc received a complaint via email.Email(s) attached.We would like to report an issue related to 3cc syringe (309575) lot # 5083505, expiration 28 feb 2030 (02-28-2030).On 12 nov 2025 (11-12-2025), it was reported by one of our customers that a brown substance was observed on the barrel of the syringe near the flange.The syringe was returned to us today, and upon investigation, the brown substance seems to be incorporated in the plastic (it did not scrape off or wipe off with ipa).Please see attached photos.I have kept the physical syringe, as it was not injected into a patient, if required to send to you for investigation.
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.A brown substance was reported on the syringe barrel near the flange.To support the investigation, the quality team received one sample and one photograph of a 3ml luer lok syringe with a 21gx1 inch needle for evaluation.Visual assessment of the sample identified multiple areas of discoloration embedded within the barrel, consistent with embedded foreign matter.The photograph similarly depicts discoloration on the barrel flange of an individual, loose syringe.This condition is nonconforming to the product specification and is attributable to the molding process.Specifically, embedded degraded resin can occur when resin is exposed to prolonged elevated temperatures within the molding machine, such as during start up.This defect is cosmetic in nature and does not pose a risk to the customer.A device history record review was completed for material number 309575, lot 5083505.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the approved inspection control plan, released for shipment, and is considered compliant with product specification requirements.Based on the investigation, the customer reported symptom is confirmed.

• Brand Name: BD SYRINGE 3ML LL W/NDL 21X1 RB
• 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: 23798681
• Report Number: 1213809-2025-00769
• Device Sequence Number: 18463613
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(17)300228(10)5083505
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 309575
• Device Lot Number: 5083505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown