Disposable MRI Kit for 65/115 MR Injector System SSQK 65/115VS (UDI 00616258007786)Recalls & reported problems
Bayer Medical Care Inc. · Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96" CT/CV,MRI,CHINA) (60728591) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00616258007786), received between Dec 18, 2019 and Jan 6, 2022 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem4
- Contamination /Decontamination Problem3
Patient problems
- No Patient Involvement5
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: A WHITE FOREIGN BODY WAS FOUND INSIDE THE SYRINGE UPON OPENING A NEW SSQK65/115VS SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177739 ↗MalfunctionJan 6, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: A WHITE FOREIGN BODY WAS FOUND INSIDE THE SYRINGE UPON OPENING A NEW SSQK65/115VS SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13175399 ↗MalfunctionJul 2, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THE FOLLOWING: UPON OPENING THE SOLARIS MR DISPOSBLE KIT AND UPON INSPECTION, THE NOTICED FOREIGN MATERIAL WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10226346 ↗MalfunctionJul 2, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER FILLING THE SOLARIS MR DISPOSABLE SYRINGE WITH CONTRAST, A FOREIGN MATERIAL WAS SEEN WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10226134 ↗MalfunctionFeb 27, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SOLARIS DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED A FOREIGN MATERIAL WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9765509 ↗MalfunctionJan 15, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: THE CUSTOMER OBSERVED A FOREIGN MATERIAL FLOATING IN THE SSQK 65/115VS CONTRAST SYRINGE BARREL AFTER THE FILLING PROCESS. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9591988 ↗MalfunctionDec 18, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SSQK 65/115VS DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN MATERIAL ON THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9488900 ↗
Other Injector And Syringe, Angiographic devices
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- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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