MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. OMNIFIX®; SYRINGE, PISTON

Catalog Number	4617100V-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by user facility: a plastic fragment was found inside a new syringe from his supply shipment, and later noted a second new empty syringe also contained a small plastic piece, which he did not use and reported to his nurse ambassador.The patient experienced blistering and bruising at the cannula site after removal; these symptoms resolved with residual redness.He also reported new intermittent flecks/floaters and peripheral visual disturbances of uncertain cause.During a subsequent visit, the physician examined the skin and observed no signs of infection.The patient stated that the intermittent eye symptoms continued.No injury was reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.A follow up will be submitted when the investigation results become available.

• Brand Name: OMNIFIX®
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem, PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem, PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th avenue; bethlehem,, PA 18018
• MDR Report Key: 24324096
• Report Number: 9610825-2026-00080
• Device Sequence Number: 9423523
• Product Code: FMF
• UDI-Device Identifier: 04046963452223
• UDI-Public: (01)04046963452223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 4617100V-02
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown