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 /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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.Inspection two units with white embedded particulates.
Event or Problem Description
No patient harm, injury, complication or negative outcome.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported there were two units with white embedded particulates.To aid in the investigation, two samples with no packaging blisters and one photograph was received for evaluation by our quality team.The samples were received in a plastic bag labeled with lot 5135004.A visual inspection was performed.There is an embedded white speck that is acceptable in size.The photograph provided shows the samples received.No other defects or imperfections were observed.A device history record review was completed for material number 302832, lot 5135004.The review did not identify any quality issues detected during production that could have contributed to the reported condition.No related quality notifications were found, and all processes and final inspections met specification requirements.Based on the investigation and sample evaluation, the customer reported condition is confirmed, however, the size of the embedded specks is within acceptable limits.

• 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: 24147531
• Report Number: 1911916-2026-00026
• Device Sequence Number: 8859840
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(11)250522(17)300430(10)5135004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/29/2026

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: 5135004
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown