MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL LUER-LOK; SYRINGE, PISTON

Catalog Number	302830
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported opened 20 cc syringe to draw heparin around 1000, package was intact and found black specks inside the syringe.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported that black specks were observed inside the syringe.To support the investigation, one sample with an opened packaging blister was received and evaluated by the quality team.A visual inspection confirmed the presence of embedded dark colored specks within the syringe barrel, with no additional defects or irregularities identified.This type of embedded degraded resin is a known phenomenon that can occur during startup or intermittently throughout the injection molding process, during which degraded material may dislodge and become incorporated into molded components.A review of the device history record was conducted for material number 302830, lot 5273442.The review identified no quality issues during the manufacture of this lot that could have contributed to the reported condition, and no related quality notifications were noted.All manufacturing steps and final inspections were performed in accordance with established specifications.To date, no other similar events have been reported for this lot.Based on the investigation results and analysis of the returned sample, the customer reported condition has been confirmed.

• 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 ; 8473935694
• MDR Report Key: 24777491
• Report Number: 1911916-2026-00146
• Device Sequence Number: 20349887
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306(11)251003(17)300930(10)5273442
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 5273442
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown