360" COILED MRI EXTENSION SET
Received Mar 5, 2019 · Event occurred Nov 3, 2018
Report 8392216 · MDR key 8392216
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Summit Medical, Inc.Product problems
- Fluid/Blood Leak
- Manufacturing, Packaging or Shipping Problem
- Material Split, Cut or Torn
Patient
34675 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PER THE INITIAL REPORTER: THE MRI TUBING IS MANUFACTURED AND DELIVERED AS A LOOSE COIL ¿ SLINKY-LIKE. NORMALLY, DURING PREP, THE NURSES WILL PULL ON THE ENDS OF THE TUBING TO ALLOW THE TUBING TO STRETCH. THIS PARTICULAR LOT OF TUBING HAD THE COILS BONDED TOGETHER TOO STRONGLY. WHEN THE NURSE PULLED ON THE TUBING, IT RIPPED. ADDITIONALLY, THESE RIPS IN THE TUBING WERE HARD TO SPOT DURING THE PREP. THEY WEREN¿T NOTICED UNTIL THE TUBING LEAKED. THE SET WAS GIVEN TO CENTRAL SUPPLY FOR RETURN TO THE MANUFACTURER REP. UPDATE FROM THE MANUFACTURER PENDING.
Description of Event or Problem
PER THE INITIAL REPORTER: THE MRI TUBING IS MANUFACTURED AND DELIVERED AS A LOOSE COIL ¿ SLINKY-LIKE. NORMALLY, DURING PREP, THE NURSES WILL PULL ON THE ENDS OF THE TUBING TO ALLOW THE TUBING TO STRETCH. THIS PARTICULAR LOT OF TUBING HAD THE COILS BONDED TOGETHER TOO STRONGLY. WHEN THE NURSE PULLED ON THE TUBING, IT RIPPED. ADDITIONALLY, THESE RIPS IN THE TUBING WERE HARD TO SPOT DURING THE PREP. THEY WEREN¿T NOTICED UNTIL THE TUBING LEAKED.THE SET WAS GIVEN TO CENTRAL SUPPLY FOR RETURN TO THE MANUFACTURER REP. UPDATE FROM THE MANUFACTURER PENDING.