MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	956-616
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer safe pico arterial blood gas sampling kit found to clot after flash of blood.Patient sample was obtained after fourth attempt.When evaluating the cause, the respiratory therapist found that on the packaging, two different font sizes and types were noted; however, both had the same kit number, lot number and expiration date.The rt reported that the kit with smaller font would clot upon flash and small sample of blood into the syringe.Upon removal from the patient, the plunger was moved back and forth with clots expelled from the syringe.Originally, the kit with smaller font was the item found to clot x 3 different syringes and the kit with the larger font worked.However, upon discussion with rt staff, the opposite happened to a different rt (patient unknown).Given the concern, all abg kits with that lot number and expiration date were pulled from service and replaced by the radiometer rep.

• Brand Name: SAFEPICO70
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): RADIOMETER MEDICAL APS; matt ackerman; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6947400
• Report Number: 6947400
• Device Sequence Number: 13731074
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2017
• Report Date (Section F): 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2019
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: YM-52
• Other Device ID Number: 616-KIT 23G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 53
• Date Report Sent to FDA: 10/04/2017