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

Model Number 498106

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 06/29/2023

Event Type  Injury  

Event 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.

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.

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 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.

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 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"
• Type of Device: 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
• MDR Text Key: 321346511
• Report Number: 0001625425-2023-01160
• Device Sequence Number: 1
• Product Code: GDF
• UDI-Device Identifier: 00886333215577
• UDI-Public: 00886333215577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention