MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LL S/C 56; SYRINGE, PISTON

Catalog Number	302832
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It is reported foreign matter.Description: it was reported by customer that we are finding black floaties.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported that black floating particles were observed.To support the investigation, two samples in opened blister packaging and two photographs were received for evaluation.A visual inspection was conducted.One sample exhibited dark colored specks consistent with embedded degraded resin, the second sample showed no observable defects or imperfections.The photographs depict one of the returned samples.Embedded degraded resin typically occurs at startup or intermittently during the injection molding process, during which degraded material can break loose and become incorporated into molded components.A device history record review was completed for material number 302832, lot 5212042.The review did not identify any detected quality issues during production of this lot that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned samples, the customer reported condition is confirmed.

• Brand Name: SYRINGE 30ML LL S/C 56
• 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: 24278705
• Report Number: 1911916-2026-00058
• Device Sequence Number: 12834536
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)250808(17)300731(10)5212042
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 302832
• Device Lot Number: 5212042
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown