MAUDE Adverse Event Report: BECTON DICKINSON, S.A. POSIFLUSH; SALINE VASCULAR ACCESS FLUSH

Catalog Number	306546
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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
Verbatim: bedside report and ivf [intravenous fluid] rates being verified.Leaking fluid noted from medication line filter that is attached to picc [peripherally inserted central catheter].Liquid noted at site of filter, soaked label on the line and droplets noted along med line.Nothing infusing via med line at this time.Medication line had been changed the previous shift.Additional information 03-november-2025: 1, in the medsun form, the date of event is mentioned as "sep-2025".Can you please provide an exact date of event in this format mm-dd-yyyy? 09/24/2025.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Na.3.Could you please confirm where the leakage occured? the leakage happened in the posiflush syringe? near site of filter.
Additional Manufacturer Narrative
Additional information: (h) attached medsun investigation results: after dhr record review for final product and moulding batches, it can be determined that there were no issues documented related to the reported complaint.Therefore, it has not been found any specific circumstances, from manufacturing process, that could explain the described complaint.Since there are not defective samples available, twenty (20) syringes from the retained samples from the same batch have been tested for leakage (att.A).No leakage past stopper neither in the syringe tip has been detected.Defect cannot be confirmed.
Event or Problem Description
No additional information.

• 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): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23550836
• Report Number: 3002682307-2025-00129
• Device Sequence Number: 9718651
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)280229(10)5065644
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 05/14/2026

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: 5065644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 05/14/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/16/2025; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG