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

Catalog Number	306546
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
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.G.4.Additional 510k: k141311,k250884 b3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
It was reported, black dots.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there were some black dots.As a physical sample was not returned, a thorough sample evaluation could not be performed.To support the investigation, the quality team reviewed a single photograph provided by the customer.The image appears to show a syringe plunger rod against a white background, with dark colored specks visible within the plunger rod ribs.No additional defects or irregularities were observed in the photograph.A device history record review was completed for material number 306546, lot 5356778.This review did not identify any in process or final inspection nonconformances that could have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections met applicable specification requirements.At the time of this review, no other similar events have been reported for this lot.Based on the available information and photographic assessment, the condition reported by the customer is considered confirmed.However, without evaluation of an actual physical sample, a probable root cause could not be determined.

• 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: 24791909
• Report Number: 1911916-2026-00152
• Device Sequence Number: 18621675
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)281130(10)5356778
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• 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): 04/14/2026

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: 5356778
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown