CT TRI-PAK Sterile Disposable Syringe CTP-200-FLS (UDI 00616258007793)Recalls & reported problems
Bayer Medical Care Inc. · Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (ASSY,PKG,SYRINGE,TRIPAK,200ML,ODSY,MC,C) (60728664) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00616258007793), received between Nov 26, 2018 and Nov 5, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Disintegration” (3 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
- Material Disintegration3
- Material Integrity Problem3
Patient problems
- No Patient Involvement2
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2019Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT UPON OPENING TWO CTP-200-FLS SYRINGE KITS, A WHITE POWDER WAS OBSERVED ON THE SYRINGES. THE TECHNOLOGIST ELECTED NOT TO USE THE SYRINGE KIT. THERE WAS NO INJURY OR ADVERSE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9280188 ↗MalfunctionNov 5, 2019Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT UPON OPENING A CTP-200-FLS SYRINGE KIT, A WHITE POWDER WAS OBSERVED ON THE SYRINGE. THE TECHNOLOGIST ELECTED NOT TO USE THE SYRINGE KIT. THERE WAS NO INJURY OR ADVERSE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9280107 ↗MalfunctionNov 26, 2018Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT UPON OPENING 5 CTP-200-FLS SYRINGE KITS FROM THE SAME BOX, A WHITE POWDER WAS OBSERVED ON THE SYRINGES. THE KITS WERE NOT USED FOR A PATIENT AND WERE REMOVED FROM THE AREA, WITH 1 BEING SAVED TO BE RETURNED FOR INVESTIGATION.
Patient problems: Not Applicable
MAUDE report 8102419 ↗
Other Injector And Syringe, Angiographic devices
- Monarch® 00884450298022Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls37 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- 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
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
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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