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

Catalog Number	306546
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 inside syringe.Verbatim: as you can see in the photos, there appears to be an unidentified substance inside the syringe.Fortunately, the nurse caught it before use.We checked both floor stock and inventory but did not find any additional syringes from this lot, or any other lot, with similar issues.No patient harm.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that an unidentified substance was present inside a syringe.To support the investigation, thirty sealed flow wrap samples and two photographs were submitted to the quality team for evaluation.Visual inspection of all returned samples identified no defects, imperfections, or foreign matter.The photographs depict a syringe outside of its flow wrap, with brown colored specks visible.No additional information could be discerned from the images.A device history record review was completed for material number 306546, lot 5261627.The review did not identify any quality issues during manufacture that could have contributed to the reported condition, and no related quality notifications were found.All processes and final inspections met specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation, including the analysis of the photographs, the customer reported condition is confirmed.Without the physical sample reflecting the condition documented in the photographs, a probable root cause could not be determined.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• 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: 24176704
• Report Number: 1911916-2026-00037
• Device Sequence Number: 9579053
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)280930(10)5261627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/10/2026

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: 306546
• Device Lot Number: 5261627
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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