FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES
Received Jan 30, 2025 · Event occurred Jan 8, 2025
Report 21277205 · MDR key 21277205
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Bracco Injeneering SaModel number
017355Catalog number
017355
Lot number
261714
Product problems
- Burst Container or Vessel
- Nonstandard Device
- Fail-Safe Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FASTLOAD CT SYRINGE EXPLODED WHILE PERFORMING INJECTION. NO PATIENT INJURY OR HARM. AFTER EVALUATING THE LOT NUMBER, IT WAS DETERMINED THAT THIS LOT # OF SYRINGE WAS RECALLED IN DECEMBER. WE WENT THROUGH THE DEPARTMENT AND 48 CASE PLUS 300 IN THE DEPARTMENT WERE RECALLED. BRACCO HAD SENT FACILITY PRODUCTS THAT WERE RECALLED ALREADY. BOXES WITH LOT #261714 WAS RECEIVED BY OUR FACILITY JANUARY 2025. THE SYRINGE USED ON THIS PATIENT WAS PULLED FROM THIS BOX FILLED WITH THE RECALLED LOT NUMBER.
Description of Event or Problem
FASTLOAD CT SYRINGE EXPLODED WHILE PERFORMING INJECTION. NO PATIENT INJURY OR HARM. AFTER EVALUATING THE LOT NUMBER, IT WAS DETERMINED THAT THIS LOT # OF SYRINGE WAS RECALLED [REDACTED]. WE WENT THROUGH THE DEPARTMENT AND 48 CASE PLUS 300 IN THE DEPARTMENT WERE RECALLED. BRACCO HAD SENT FACILITY PRODUCTS THAT WERE RECALLED ALREADY. BOXES WITH LOT #261714 WAS RECEIVED BY OUR FACILITY [REDACTED]. THE SYRINGE USED ON THIS PATIENT WAS PULLED FROM THIS BOX FILLED WITH THE RECALLED LOT NUMBER.