MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 20GA X 3"

Model Number	498106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A radial arterial line was inserted in icu on the (b)(6) and pt transferred to icu post op.Arterial line functioning properly ¿ good trace and blood aspiration.Separation of arterial catheter from hub requiring surgical removal.At approximately 0200hrs on (b)(6) 23 the arterial waveform suddenly disappeared.On examination of the arterial line hub was still sutured in and dressing intact and site was bleeding.When dressing removed it was found that the arterial line has broken.The distal part of the line unable to be found.An xray of the patients forearm was attended and the arterial line had dislodged in the patients artery.Patient went to operating theatres for removal of the line.Pt remained neurovascularly intact throughout the incident.The patient was compliant, not agitated or moving wrist excessively.The arterial waveform was adequate and no sign of damping leading up to the arterial line snapping.
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted for the speculated lot number 11445670, and no similar concerns were found.According to the customer, there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided for this complaint which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.
Event or Problem Description
A radial arterial line was inserted in icu on the 29th june and pt transferred to icu post op.Arterial line functioning properly ¿ good trace and blood aspiration.Separation of arterial catheter from hub requiring surgical removal.At approximately 0200hrs on 2/7/23 the arterial waveform suddenly disappeared.On examination of the arterial line hub was still sutured in and dressing intact and site was bleeding.When dressing removed it was found that the arterial line has broken.The distal part of the line unable to be found.An xray of the patients forearm was attended and the arterial line had dislodged in the patients artery.Patient went to operating theatres for removal of the line.Pt remained neurovascularly intact throughout the incident.The patient was compliant, not agitated or moving wrist excessively.The arterial waveform was adequate and no sign of damping leading up to the arterial line snapping.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot could not be conducted since a lot number was not provided.According to the customer, there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided for this complaint which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.
Event or Problem Description
A radial arterial line was inserted in icu on the (b)(6) and pt transferred to icu post op.Arterial line functioning properly ¿ good trace and blood aspiration.Separation of arterial catheter from hub requiring surgical removal.At approximately 0200hrs on (b)(6)2023 the arterial waveform suddenly disappeared.On examination of the arterial line hub was still sutured in and dressing intact and site was bleeding.When dressing removed it was found that the arterial line has broken.The distal part of the line unable to be found.An xray of the patients forearm was attended and the arterial line had dislodged in the patients artery.Patient went to operating theatres for removal of the line.Pt remained neurovascularly intact throughout the incident.The patient was compliant, not agitated or moving wrist excessively.The arterial waveform was adequate and no sign of damping leading up to the arterial line snapping.

• Brand Name: ARTERIAL LINE KIT/1 20GA X 3"
• 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: 17564860
• Report Number: 0001625425-2023-01160
• Device Sequence Number: 20548713
• Product Code: GDF
• UDI-Device Identifier: 00886333215577
• UDI-Public: 00886333215577
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 498106
• Was Device Available for Evaluation?: No
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/01/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 08/28/2023; 09/26/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown