MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL POSIFLUSH; 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	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There is a foreign body inside the syringe.Looks to be a broken piece from another syringe.
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: it was reported that a foreign body was present inside the syringe, appearing to be a broken fragment from another syringe.Because a physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, five photographs were provided and reviewed by the quality team.The images show a syringe without flow wrap packaging containing approximately 8ml of solution, within which a piece of plastic is visible.No additional defects or imperfections were observed.A device history record review was completed for material number 306547, lot 5275833.The review identified no quality issues detected during production that could have contributed to the reported condition, and no related quality notifications were recorded.All processes and final inspections complied with applicable specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and the photographic evidence, the customer reported symptom is confirmed.However, in the absence of the physical sample, a probable root cause could not be determined.
Event or Problem Description
No adverse event or injury, rn noticed before administration to the patient.

• Brand Name: POSIFLUSH
• 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: 24379439
• Report Number: 1911916-2026-00074
• Device Sequence Number: 13417525
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280930(10)5275833
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• 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): 03/04/2026

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: 5275833
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown