MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 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	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
We had some contamination of syringes we found customer response: on (b)(6) 2025.Can you please provide an exact date of event in this format mm-dd-yyyy? 11/13/2025.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm, injury, ns flush that looked orange and with particles in it.The syringe is completely sealed in its packaging.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation to support the investigation, one sample without its flow-wrap packaging was provided for evaluation by the quality team.A visual inspection was conducted, during which the solution was noted to be discolored, and foreign matter was observed at the bottom of the syringe barrel near the upper portion of the tip cap.No additional defects or imperfections were identified.The sample was subsequently sent to an external laboratory for analysis.The closest material match for the foreign matter was talc; however, the correlation percentage was low, and the result was deemed inconclusive.A device history record review was completed for material number 306546, lot 5175928.The review did not identify any quality issues during the manufacture of this lot that could explain the reported condition.No related quality notifications were found, and all processes and final inspections were performed in accordance with specification requirements.To date, there have been no other similar reports associated with this lot.Based on the investigation and the analysis of the returned sample, the customer¿s reported condition is confirmed.

• Brand Name: POSIFLUSH
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; s/n; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23733018
• Report Number: 3002682307-2025-00136
• Device Sequence Number: 9667734
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)280630(10)5175928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 5175928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown