MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG OMNIFIX®; SYRINGE, PISTON

Catalog Number	US4617509F-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: clean room staff brough to my attention that they found multiple syringes with some sort of liquid right by the plunger where it meets the tip from what we think could be oil/lubricant to stop the plunger from sticking.I am told other branches are experiencing this as well.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A total of eight (8) samples (7 samples in original packaging and 1 unused sample in open packaging) and one (1) photo was submitted to the manufacturer for evaluation.Through visual examination of the samples, no drops of substance in the syringe were detected.Through visual examination of the photo, an accumulation of silicone oil, not an excess, was observed.Silicone oil is a component of the medical device and is needed to guarantee the sliding properties of the piston, to prevent the stick slip effect, when dispensing medication.The maximum tolerable quantity of silicone oil is 25.67 mg per syringe.The siliconization process is monitored and documented per week.The batch 21m23d8004 measurements of the silicone test were between 11.8 mg 13.4 mg and show significant lower results.A review of the batch record was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.Based on the investigation of the received samples and photo, the received samples are within specification.Based on the photo and review of silicone oil testing for batch 21m23d8004, the samples are within specification.The reported defect is not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: OMNIFIX®
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20277907
• Report Number: 9610825-2024-00739
• Device Sequence Number: 18116997
• Product Code: FMF
• UDI-Device Identifier: 04046964723247
• UDI-Public: (01)04046964723247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/19/2024

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: US4617509F-02
• Device Lot Number: 21M23D8004
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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