MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL POSIFLUSH; PERIPHERAL IV CATHETERS

Catalog Number	306547
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation.A customer reported the presence of a broken syringe tubing fragment inside a flush syringe.To support the investigation, one sample without flow wrap packaging was received and evaluated by the quality team.Visual inspection confirmed a plastic fragment consistent with material from another syringe barrel inside the syringe.No additional defects or imperfections were observed.This condition could occur if a jam occurred at the fill machine.A device history record review was completed for material number: 306547, lot: 5238612.The review did not identify any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections were performed in accordance with specification requirements.Verification of the fill machine was conducted the settings and rail alignment were correct, and product flow was satisfactory.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syr 10ml pump compatible saline 10ml fil had foreign matter.The following information was provided by the initial reporter: material#: 306547 batch#: 5238612 rcc received a complaint via email.Xxx mdip reference number (id): (b)(4) date of incident: (b)(6) 2025 type of incident/problem: a2.Failure.(i.E.While preparing for, in use, after use) level of harm: xxxx optional report to (b)(6): incident details: pt was showing signs of discomfort, despite being sedated on an infusion of propofol.Nurse asked for an order of toradol which was ordered by the resident assigned to the pt.Nurse prepared and administered the ordered dose.As the nurse completed flushing the medication through the pt's iv line, they noticed something floating in the prepackaged saline flush syringe.Upon further inspection the nurse noted what appears to be a piece of broken syringe tubing inside the flush syringe that had just been used to flush the pt's iv.Nurse did not note any resistance while flushing the iv and the pt appeared unbothered as well.The iv site remains intact, with no swelling, or leaking.Nurse notified charge nurse and immediately submitted the rls report.Unexpected or prolonged care? yes frequency of problem: other device/incident factors: invasive procedure? procedure: 10ml normal saline flush physician: device information device name/description: syringe flush bd posiflush saline 10 ml intravenous fill preservative free sterile latex free manufacturer: becton dickinson canada inc manufacturer code/model: 306547 serial or lot number: (b)(6) expiry date: 2028-08-31 supplier:(b)(4) supplier/catalogue number: bd306547 is the device retained? yes number of devices: 1 wiped, contained, labelled? wiped, doubled bagged (if consumable), and labelled as per instructions device handling hazards (when blank = hazards not specified) none.

• Brand Name: POSIFLUSH
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 23994309
• Report Number: 1911916-2025-00835
• Device Sequence Number: 16008166
• Product Code: FOZ
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 5238612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown