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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that item is dirty inside sealed package.It was on both ends of the product still inside the original packaging.No patient harm.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A complaint was received reporting that the item appeared dirty within a sealed package.One sealed, blister packaged sample was received by the quality team for evaluation, and a visual inspection was performed.Inspection of the syringe barrel identified embedded degraded resin at the barrel flange and at the 15ml and 20ml graduation marks.No other defects or imperfections were observed.Embedded degraded resin is a known condition that can occur at startup or intermittently during the injection molding process when degraded material detaches and is inadvertently molded into the component.A device history record review was completed for material number 302830, lot 5303684.The review did not reveal any quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were documented as compliant with specification requirements.The sample will be used to increase associate awareness.Based on the investigation and analysis of the returned sample, the customer reported condition is 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: 24470800
• Report Number: 1911916-2026-00092
• Device Sequence Number: 16035317
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306(11)251031(17)300930(10)5303684
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 5303684
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown