MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306547
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that look like "mold" on the saline syringes in multiple boxes.Initial description: material 306547 lot 5261637.I am reaching out regarding a product report from one of our sites.Please find below the incident details and all relevant information needed for your internal team to review and process the report.I¿ve attached images as well.Good catch as anesthesia noticed what appears to look like "mold" on the saline syringes in multiple boxes that were to be stocked.All product was removed.
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 report was received indicating suspected mold on saline syringes in multiple boxes.To support the investigation, the quality team received eight five samples in sealed, flow wrapped packaging and two photographs for evaluation.A visual inspection was performed, and sixteen samples were observed to have brown specks on the tip cap.The photographs depicted one of the submitted samples and one of the packaging boxes.One sample was submitted to an external laboratory for analysis.The laboratory confirmed the material was not embedded and was not mold; however, there was insufficient material available to perform fourier transform infrared (ftir) spectroscopy.A device history record review was completed for material number 306547, lot 5261637.The review did not identify any in process or final inspection issues during manufacture that would be expected to contribute to the reported condition.No related quality notifications were identified, and all processing steps and final inspections met applicable specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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: 24116561
• Report Number: 1911916-2026-00019
• Device Sequence Number: 9696846
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280930(10)5261637
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• 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): 02/06/2026

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: 306547
• Device Lot Number: 5261637
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown