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	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that observed multiple black, bubbled specks embedded within the barrel of the syringe.
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.B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.The presence of multiple black, bubbled specks embedded within the syringe barrel was reported.To support the investigation, one sample in a sealed blister package was provided to the quality team for evaluation.A visual inspection was conducted, during which no defects, imperfections, or foreign matter were observed on the syringe itself.Particles were identified on the inner wall of the blister top web within the sealing area, however, no additional defects or irregularities were noted.This condition may be attributable to insufficient cleaning following equipment repair or maintenance activities.A device history record review was performed for material number 302830, lot 6035210.The review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were associated with this lot.All manufacturing processes and final inspections were completed in accordance with specification requirements.The sample will be shared with associates for awareness purposes.To date, no other similar events have been reported for this lot.Based on the completed investigation and analysis of the returned sample, the condition reported by the customer 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: 24830238
• Report Number: 1911916-2026-00166
• Device Sequence Number: 16007507
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/12/2026

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: 6035210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown