MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG OMNIFIX; HYPODERMIC SYRINGE

Model Number	4251601-020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in germany: "stamp of syringe is leaky." "leakage of heparin syringe, stamp (rubber) leaking.48 min after start of treatment.No device alarm.Personal injury: approx.400 ml blood loss.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).We received one used and contaminated 30 ml syringe from the competitor infuject.The syringe is filled with approx.15 ml blood.The syringe is not a bbm product.Therefore, no further investigation is possible.As no bbm sample (bbm product) was provided for testing, no further testing can be performed.The complaint is only taken to knowledge and filed for statistical purposes.

• Brand Name: OMNIFIX
• Common Device Name: HYPODERMIC SYRINGE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; carl-braun-str. 1; melsungen, PA 34212 ; 4847197287
• MDR Report Key: 15249770
• Report Number: 9610825-2022-00345
• Device Sequence Number: 5808859
• Product Code: KZH
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 4251601-020
• Device Catalogue Number: 4617304F
• Device Lot Number: 20N07C8
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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