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

Catalog Number 956-616

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Venipuncture (2129)

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.
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manufacturer response for safepico arterial blood gases syringe, safepico (per site reporter).
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awaiting the manufacturer's response.

• Brand Name: SAFEPICO
• Type of Device: ARTERIAL BLOOD SAMPLING
• Manufacturer (Section D): RADIOMETER AMERICA, INC; * ; *
• MDR Report Key: 3820090
• MDR Text Key: 4504166
• Report Number: 3820090
• Device Sequence Number: 1
• Product Code: CBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 956-616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2014
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 133