MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL Luer-Lok; Syringe, Piston

Catalog Number	302830
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4)follow up for device evaluation it was reported that black ink-like residue was present within the syringe.To support the investigation, forty-four samples and one photograph were received and evaluated by the quality team.Of the returned samples, forty two were received in sealed blister packaging, while two were received without packaging.A visual inspection was performed on all samples.The two unpackaged samples exhibited embedded dark-colored specks within the material, no additional defects or abnormalities were observed.The photograph provided shows some of the samples received.Based on the evaluation, the observed condition is consistent with degraded resin embedded within the molded component.This type of material degradation can occur during injection molding startup activities or intermittently throughout the molding process, where degraded resin may dislodge and become incorporated into the finished component during molding.A device history record review was conducted for material number 302830, lot 6169513.The review did not identify any manufacturing, processing, or inspection anomalies that could have contributed to the reported condition.Additionally, no related quality notifications were identified.All manufacturing operations and final product inspections were completed in accordance with established specifications and acceptance criteria.Based on the investigation results and the evaluation of the returned samples, the reported customer concern is confirmed.The observed black ink like residue correlates to embedded degraded resin within the molded component.

• Brand Name: Luer-Lok
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50917220
• Report Number: 1911916-2026-00521
• Device Sequence Number: 17528993
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/25/2026

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: 302830
• Device Lot Number: 6169513
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown