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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMMIT MEDICAL, INC. 360" COILED MRI EXTENSION SET; TUBING, FLUID DELIVERY
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SUMMIT MEDICAL, INC. 360" COILED MRI EXTENSION SET; TUBING, FLUID DELIVERY Back to Search Results
Device Problems Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2018
Event Type  malfunction  
Event Description
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.
 
Event Description
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.
 
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Brand Name
360" COILED MRI EXTENSION SET
Type of Device
TUBING, FLUID DELIVERY
Manufacturer (Section D)
SUMMIT MEDICAL, INC.
20 addison ave.
franklin MA 02038
MDR Report Key8392216
MDR Text Key137928127
Report Number8392216
Device Sequence Number1
Product Code FPK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 12/23/2018,11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2018
Event Location Hospital
Date Report to Manufacturer02/13/2019
Patient Sequence Number1
Patient Age34675 DA
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