inforMED
MalfunctionFPK

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Received Apr 24, 2013 · Event occurred Apr 3, 2013

Report 3113351 · MDR key 3113351

Device

Generic name

Tubing, Fluid Delivery

Manufacturer

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Model number

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Catalog number

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Lot number

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Product problems

  • Break
  • Detachment Of Device Component

Patient

44 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHEN IV TUBING WAS DISCONTINUED TO FLUSH PATIENT'S IV, THE TIP OF THE SMALL EXTENSION AND 7" SMALL BORE PRESSURE INFUSION SET WITH THE CLEAR MICROCLAVE, PURPLE CLAMP BROKE OFF AT THE POINT OF CONNECTION INTO THE HOSPIRA J-LOOP EXTENSION SET. THIS RESULTED IN A WHOLE NEW J-LOOP NEEDING TO BE APPLIED TO THE HUB OF THE IV CANNULA. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV TUBING WAS DISCONTINUED TO FLUSH PATIENT'S IV.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.