MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD MARK V PROVIS FOOT SWITCH WITH CABLE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	KMA 562-I
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Radiology staff discovered there was not an airtight connection between the tip of the contrast syringe with the tubing, and under aspiration there was a seal distally but proximally there was not a seal.After investigation a leak was found which allowed air into the tubing.The leak is due to the syringe and contrast tubing not adequately fitting.Air was injected into the patient and was seen on imaging.Repeat imaging showed that the air was quickly re-absorbed and the patient had no adverse effects.The patient was monitored for a few hours post procedure with no complications.

• Brand Name: MEDRAD MARK V PROVIS FOOT SWITCH WITH CABLE
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 10312083
• Report Number: 10312083
• Device Sequence Number: 859241
• Product Code: DXT
• UDI-Device Identifier: 00616258020808
• UDI-Public: (01)00616258020808
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2020
• Report Date (Section F): 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: KMA 562-I
• Device Catalogue Number: KMA 562-I
• Device Lot Number: 8413343
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 06/30/2020