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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER AMERICA, INC SAFEPICO ARTERIAL BLOOD SAMPLING

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RADIOMETER AMERICA, INC SAFEPICO ARTERIAL BLOOD SAMPLING Back to Search Results
Catalog Number 956-616
Event Date 04/14/2014
Event Type  Malfunction  
Event Description

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.

 
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Brand NameSAFEPICO
Type of DeviceARTERIAL BLOOD SAMPLING
Manufacturer (Section D)
RADIOMETER AMERICA, INC
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MDR Report Key3820090
Report Number3820090
Device Sequence Number1
Product CodeCBF
Report Source User Facility
Type of Report Initial
Report Date 05/15/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number956-616
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/15/2014
Event Location Hospital
Date Report TO Manufacturer05/20/2014

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