MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	303537
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
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.In this mdr, bd columbus, ne has been listed in sections d.3.And g.1.Device(s) manufactured in a facility that does not manufacture devices for the us market.
Event or Problem Description
It was reported, syringe 10ml saline fill china sp, foreign matter.The following was provided by the initial reporter: before infusion, the patient planned to perform a flushing tube but found an abnormality at the prefilling connector, a white plastic substance blocking the connector, so it was immediately not used.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Since no sample was available for return and no pictures were retained, the defect reported by the customer could not be confirmed.

• Brand Name: SYRINGE 10ML SALINE FILL CHINA SP
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• 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: 25548235
• Report Number: 1911916-2026-00340
• Device Sequence Number: 13446776
• Product Code: NGT
• UDI-Device Identifier: 30382902976395
• UDI-Public: (01)30382902976395(17)261111(10)5316858
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: 303537
• Device Lot Number: 5316858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown