MAUDE Adverse Event Report: SAM MEDICAL PRODUCTS SAM IO INTRAOSSEOUS ACCESS SYSTEM; INTRAOSSEOUS ACCESS SYSTEM CATHETER

Model Number	SAM IO NEEDLE SET 25MM
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 27 y/o male encountered a potentially critical occurrence of a chronic condition while in a extremely difficult location to access by first responders.The patient was extricated then moved to an area where care could be provided.Once care was started a paramedic attempted 3 peripheral iv's without success and then successfully inserted a 25mm sam io needle set in left proximal tibia.Once the sam io needle set was inserted the paramedic was unable to seperate the stylet from the cannula so the io needle set was removed resulting in a potential delay of patience care.The patient was transported to a local hospital where the ed staff immediately attempted peripheral vascular access two additional times without success.The ed physician simutaneously prepared the patient for central venous access which was successful.
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation and it was determined the most likely cause of the issue is an out of tolerance condition of the tab width of the stylet adaptor and/or the width of the slot of the stylet adaptor.

• Brand Name: SAM IO INTRAOSSEOUS ACCESS SYSTEM
• Common Device Name: INTRAOSSEOUS ACCESS SYSTEM CATHETER
• Manufacturer (Section D): SAM MEDICAL PRODUCTS; 12200 sw tualatin road; suite 200; tualatin OR 97062
• Manufacturer (Section G): SAM MEDICAL PRODUCTS; 12200 sw tualatin road; suite 200; tualatin OR 97062
• Manufacturer Contact: jeff lipps ; 12200 sw tualatin road; suite 200; tualatin, OR 97062 ; 5036395474
• MDR Report Key: 19148833
• Report Number: 3023316-2024-00001
• Device Sequence Number: 15314386
• Product Code: FMI
• UDI-Device Identifier: 00822045000285
• UDI-Public: (01)00822045000285(10)25A220802A(17)270722
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Model Number: SAM IO NEEDLE SET 25MM
• Device Catalogue Number: IO706-1P-EN
• Device Lot Number: 25A220802A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Male