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

Catalog Number	306546
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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
Went to flush iv with prefilled 10ml posiflush and drew blood return into syringe, realized the syringe was filled with air, no saline.No air was injected into the iv, no impact to pt.Syringe was disconnected from iv site and placed aside.New flush was connected and used without incident.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation the syringe was reported to be filled with air.To support the investigation, one sample without flow wrap packaging was received for evaluation by the quality team.A connector and a blue cap were present at the syringe barrel luer in place of the original white cap.No saline was present, however, droplets of a clear solution were observed, possibly residual from the decontamination process.No additional information could be obtained from the sample.An empty syringe condition may occur as a result of a jam at the solution filling station.A device history record review was completed for material number 306546, lot 5218281.The review identified no 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.Verification of the filling station confirmed that settings were correct, and product flow was acceptable.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned sample, the customer reported condition is 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: 24424636
• Report Number: 1911916-2026-00078
• Device Sequence Number: 12247206
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)280731(10)5218281
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/05/2026

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: 306546
• Device Lot Number: 5218281
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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 Sex: Unknown