MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD STELLANT FLEX SYRINGE KITS; ANGIOGRAPHIC INJECTOR AND SYRINGE

Model Number	87078752
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the customer discarded the syringe kit that was in use during the incident, bayer product analysis received and examined an unused medrad® stellant flex disposable syringe kit from the same lot (flexd-150-spk, lot number 8659907) provided by the customer.Functional testing of the unused products confirmed that they performed to specification with no leaks observed.The device history record (dhr) for batch number 8659907 was reviewed for any indications of non-conformities as well as any other deviations.This review concluded that there were no non-conformities or alert/action limits reached during the in-line inspection of this batch.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
The customer reported connection and leaking issues while using a medrad® stellant flex disposable syringe kit (flexd-150-spk, lot number 8659907).The contrast had leaked onto the floor upon which the technologist subsequently slipped and fell.After being evaluated in the emergency room, the employee was released back to work with no issues reported.

• Brand Name: MEDRAD STELLANT FLEX SYRINGE KITS
• Common Device Name: ANGIOGRAPHIC INJECTOR AND SYRINGE
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 21582422
• Report Number: 2520313-2025-00008
• Device Sequence Number: 21056719
• Product Code: DXT
• UDI-Device Identifier: 00616258022833
• UDI-Public: (01)00616258022833(11)241101(17)281101(10)8659907
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K173773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 87078752
• Device Catalogue Number: FLEXD-150-SPK
• Device Lot Number: 8659907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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