inforMED
MalfunctionCBF

SAFEPICO

Received May 15, 2014 · Event occurred Apr 14, 2014

Report 3820090 · MDR key 3820090

Device

Generic name

Arterial Blood Sampling

Model number

*

Catalog number

956-616

Lot number

*

Product problems

  • Device Operates Differently Than Expected

Patient

45 YR

  • Venipuncture

Narrative

Description of Event or Problem

TECHNICIAN DREW AN ARTERIAL BLOOD GAS ON PATIENT TO ASSESS RESPONSE TO BEING ON BIPAP. AFTER THE SAMPLE WAS OBTAINED, THE NEEDLE WAS REMOVED AND THE CAP PLACED ON THE SYRINGE. THE TECHNICIAN PUSHED THE PLUNGER SLIGHTLY TO EXPEL ANY AIR BUBBLES. THE BLOOD BACKED UP DIRECTLY INTO THE PLUNGER. THE SAMPLE WAS UNUSABLE AND REQUIRED A REDRAW FOR ARTERIAL BLOOD GASES DELAYING PATIENT CARE.======================MANUFACTURER RESPONSE FOR SAFEPICO ARTERIAL BLOOD GASES SYRINGE, SAFEPICO (PER SITE REPORTER).======================AWAITING THE MANUFACTURER'S RESPONSE.