MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306547
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 cloudy saline syringe.Describe the event or problem: the nurse grabbed a saline flush out of the storage container and noted that the syringe was cloudy.The lot number was written down.Looked through all the other saline syringes present and no other cloudiness was noted.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that the syringe was cloudy.To support the investigation, one sample without flow wrap packaging was received and evaluated by the quality team.The sample featured a green connector in place of the specified white tip cap, which did not provide an adequate seal and resulted in leakage of the saline solution.A visual inspection was performed, the syringe contained 6.5 ml of solution, and no defects or imperfections were observed.Appearance and clarity testing was conducted in accordance with applicable standards, and the unit met the acceptance criteria.A device history record review was completed for material number 306547, lot 5218232.The review identified no quality issues during manufacture or inspection that could have contributed to the reported condition.No related quality notifications were found.All processes and final inspections complied with specification requirements.To date, no similar events have been reported for this lot to date.Based on the investigation and analysis of the returned sample, the customer¿s reported symptom could not be confirmed.

• 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: 24443443
• Report Number: 1911916-2026-00083
• Device Sequence Number: 18718941
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280731(10)5218232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare 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: 5218232
• Was Device Available for Evaluation?: No
• 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: 02/25/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Unknown