MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. SPECTRIS SOLARIS SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	86594218
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® spectris solaris injection system (serial number 43647) has been scheduled.The ssqk 65/115vs disposable kit (lot number 8422773) that was in use during the event is being returned for evaluation.Once the investigation is completed, a follow-up report will be submitted.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
Bayer medical care inc.Was informed that, while preparing the medrad® spectris solaris mr injection system for a procedure, the disposable syringe broke.This resulted in a piece of the syringe, as well as the contrast media contained within the syringe, striking the medical assistant in the face and eye.The user's eye was flushed with saline, and they were sent for evaluation at an urgent care facility.The staff member has been reported as doing well following this evaluation.
Additional Manufacturer Narrative
A system service check of the medrad® spectris solaris injection system (serial number (b)(6)) dated (b)(6) 2023 found the system to be performing to specification.Bayer product analysis received and examined the medrad® ssqk 65/115vs mr disposable syringe (lot number 8422773) that was in use during the event.Visual examination confirmed one large plastic fragment had broken off at the neck of the contrast syringe.Further examination identified that the plunger was located slightly above the top of the normal point of travel.Communication with the customer determined that the operator of the injector had attached the connector tubing to the syringe prior to retracting the piston, which would have created a vacuum.This caused the plunger to accelerate rapidly toward the tip of the syringe when it was removed from the injector, thereby causing it to break.The spectris solaris ep operations manual provides the following warning about syringe failure: serious injury or death may result from syringe failure.Do not retract pistons with connector tubing installed.Retracting the pistons with the connector tubing installed on syringes will create a vacuum in the syringe due to the check valve in the connector tubing.This vacuum may accelerate the plunger rapidly toward the tip of the syringe when it is removed from the injector causing the syringe to break.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: for udi data discrepancy/mismatch on previously submitted mdr and to ensure the device identification data is in alignment with gudid.

• Brand Name: SPECTRIS SOLARIS SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• 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: 18005449
• Report Number: 2520313-2023-00027
• Device Sequence Number: 20758873
• Product Code: DXT
• UDI-Device Identifier: 00616258021607
• UDI-Public: (01)00616258021607(11)230822(17)280822(10)8422773
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K012950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 86594218
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8422773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/27/2023; Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/17/2023; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female