MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 20GA X 6"

Model Number	498100
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
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
Additional Manufacturer Narrative
Sample is indicated as being returned.As of the date of this report, investigation has not been completed.A follow-up will be provided once the device has been reviewed.
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
A review of the dhr and inspection records was conducted, and no similar concerns were found.10 sealed samples were returned for review.All the samples were opened by the analyst and functionally and dimensionally tested.All of the 10 samples were confirmed to have a.025 guidewire included in the sealed kit instead of an.021 guidewire.The most probable cause is that two guidewire lots 11372127 and 11372062 got mixed up during the cleaning process.The wires are placed in different baskets during cleaning.The baskets are numbered and there¿s a paper on the machine that identifies which lots are in each basket.The operator inadvertently pulled from the incorrect basket and switched the two lots.Capa ca-00001 was initiated to document the root causes that lead to the release of mixed parts and the capa will establish the corresponding corrective actions.
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.

• Brand Name: ARTERIAL LINE KIT/1 20GA X 6"
• Common Device Name: ARTERIAL LINE KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12783339
• Report Number: 0001625425-2021-01122
• Device Sequence Number: 4265025
• Product Code: GDY
• UDI-Device Identifier: 00886333215539
• UDI-Public: 00886333215539
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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: 04/15/2026
• Device Model Number: 498100
• Device Catalogue Number: 498100
• Device Lot Number: 00886333215539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021; 10/15/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/06/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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