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

Catalog Number	306547
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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.B3.Date of event unknow.The date received by manufacturer has been used for this field.
Event or Problem Description
It is reported pump compatibility issues.Event description: when using these saline flushes, the pumps will continuously beep occluded.Outcome: infusion interruptions, need to replace saline.
Additional Manufacturer Narrative
Pr (b)(6) follow up for device evaluation.It was reported that, when using these saline flushes, infusion pumps continuously alarm with an occlusion alert.To support the investigation, four hundred twenty samples in sealed blister packaging were received for evaluation by the quality team.Fifty samples were randomly selected for testing.Visual inspection did not identify any defects or imperfections.Each selected sample was then evaluated for sustaining force, defined as the force applied to the plunger rod during downward travel while expelling the saline solution, and all results met specification requirements.A device history record review was completed for material number 306547, lot 5262073.The review did not identify any quality issues during production of this lot that could have contributed to the reported condition.No related quality notifications were identified.All manufacturing processes and final inspections were performed in accordance with established specifications and acceptance criteria.Based on the investigation and the returned sample evaluation, the customer 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: 24145013
• Report Number: 1911916-2026-00025
• Device Sequence Number: 9357272
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280831(10)5262073
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/05/2026

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: 5262073
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown