MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 18GA X 6"

Model Number	498104
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per md : defective : the supplies in each kit do not match what is on the box and they were made defective.In each kit, there is a finder needle, then a guide wire that goes thru the needle, then a catheter that goes over the wire.In all cases identified, the guidewires were unable to be thread into the needle while the needle is already in a pulsating artery.In one of the cases, the guide wire was able to be inserted thru the needle, but the catheter did not fit over the wire, which resulted in us pulling another bigger gauge case/catheter to slip over the wire.In summary, multiple instances have occurred where the 3 components are not of the same size (either 18g or 20g) or made so in that they don¿t properly fit.This resulting in harm to the patient, time lost, multiple pokes, and blood loss.
Additional Manufacturer Narrative
Per the customer, no sample was available for return and no photographic evidence provided.Without such evidence, the complaint cannot be confirmed and a definite root cause cannot be established.If more information becomes available in the future, a follow-up report will be submitted.

• Brand Name: ARTERIAL LINE KIT/1 18GA X 6"
• Common Device Name: ARTERIAL LINE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: gedaa hassan ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 12783116
• Report Number: 0001625425-2021-01121
• Device Sequence Number: 4265021
• Product Code: GDY
• UDI-Device Identifier: 00886333215553
• UDI-Public: 00886333215553
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K780871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 498104
• Device Catalogue Number: 498104
• Device Lot Number: 11377469
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown