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	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported, syr 10ml pump compatible saline 10ml, plungers are ¿sticky¿/higher friction, not allowing to infuse medications via the syringe pumps.No patient harm.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.G.4.Additional 510k: k003553.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported that the plungers exhibited elevated friction, preventing medication infusion via syringe pumps.To support the investigation, two empty samples were received by the quality team, no flow-wrap packaging was provided.A visual inspection was performed, and no defects or abnormalities were observed.The samples were subsequently evaluated for sustaining force, defined as the force applied to the plunger rod during downward travel while expelling solution, and all results met specification requirements.A device history record review was completed for material number 306547, lot 5295412.This review did not identify any in process or final inspection issues that could have contributed to the reported condition, and no related quality notifications were identified.All manufacturing processes and final inspections for this lot were performed in accordance with applicable specifications.Based on the investigation and returned sample analysis, the customer reported condition 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: 25122923
• Report Number: 1911916-2026-00207
• Device Sequence Number: 10646431
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280930(10)5295412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 5295412
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown