MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL MINI KIT

Model Number	498107
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patient admitted (b)(6) 2023 and artline was inserted on the (b)(6)2023, no issues noted on insertion, good wave line etc noted.Artline worked normally until morning of (b)(6) 2023.On the (b)(6) 2023 nurses were concerned with readings on the monitor and investigated and noticed blood accumulated and spurting from the radial access site and that the radial artline had detached whilst on patient¿s arm & the line is left in the arm.(note: line is still in the arm and will be surgically removed during the next few days.) see attached picture.Procedure stage (select one): before use/patient contact/pre-op during use/procedure/intra-op after initial use/patient treatment n/a (product not used) were accessory devices or other manufacturer¿s.
Additional Manufacturer Narrative
Sample is not available for return.An image was provided for the investigation.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Patient admitted (b)(6) 2023 and artline was inserted on the (b)(6) 2023, no issues noted on insertion, good wave line etc noted.Artline worked normally until morning of (b)(6) 2023.On the (b)(6) 2023 nurses were concerned with readings on the monitor and investigated and noticed blood accumulated and spurting from the radial access site and that the radial artline had detached whilst on patient¿s arm & the line is left in the arm.(note: line is still in the arm and will be surgically removed during the next few days.) see attached picture procedure stage (select one): before use/patient contact/pre-op during use/procedure/intra-op after initial use/patient treatment n/a (product not used) were accessory devices or other manufacturer¿s.
Additional Manufacturer Narrative
A review of the dhr and inspection records for the speculated lots: 11427594, 11445161, 11451909 and 11453691 was conducted, and no similar concerns were found.According to the customer, there was no sample available for review.However, an image was provided that was consistent with the reported issue of breakage.A review of the image confirmed breakage of the catheter tubing from inside the strain relief.There appears to be a remnant of tubing left inside the strain relief.Without the sample to review, the results are inconclusive.
Event or Problem Description
Patient admitted on (b)(6) 2023 and artline was inserted on (b)(6) 2023, no issues noted on insertion, good wave line etc noted.Artline worked normally until morning on (b)(6) 2023.On (b)(6) 2023, nurses were concerned with readings on the monitor and investigated and noticed blood accumulated and spurting from the radial access site and that the radial artline had detached whilst on patient¿s arm & the line is left in the arm.(note: line is still in the arm and will be surgically removed during the next few days).Procedure stage (select one): before use/patient contact/pre-op during use/procedure/intra-op after initial use/patient treatment n/a (product not used) were accessory devices or other manufacturer¿s.
Additional Manufacturer Narrative
Adding updated product and udi number.
Event or Problem Description
Patient admitted on (b)(6) 2023 and artline was inserted on (b)(6) 2023, no issues noted on insertion, good wave line etc noted.Artline worked normally until morning on (b)(6) 2023.On (b)(6) 2023, nurses were concerned with readings on the monitor and investigated and noticed blood accumulated and spurting from the radial access site and that the radial artline had detached whilst on patient¿s arm & the line is left in the arm.(note: line is still in the arm and will be surgically removed during the next few days).Procedure stage (select one): before use/patient contact/pre-op during use/procedure/intra-op after initial use/patient treatment n/a (product not used) were accessory devices or other manufacturer¿s.
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.However, an image was provided that was consistent with the reported issue of breakage.A review of the image confirmed breakage of the catheter tubing from inside the strain relief.There appears to be a remnant of tubing left inside the strain relief.Without the sample to review, determining a definite root cause a for the catheter breakage and a corrective action to address the issue is not possible.The area supervisor was made aware of this complaint and provided the image for review.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
Patient admitted (b)(6)2023 and artline was inserted on the (b)(6)2023, no issues noted on insertion, good wave line etc noted.Artline worked normally until morning of (b)(6)2023.On the (b)(6)2023 nurses were concerned with readings on the monitor and investigated and noticed blood accumulated and spurting from the radial access site and that the radial artline had detached whilst on patient¿s arm & the line is left in the arm.(note: line is still in the arm and will be surgically removed during the next few days.) see attached picture procedure stage (select one): before use/patient contact/pre-op during use/procedure/intra-op after initial use/patient treatment n/a (product not used) were accessory devices or other manufacturer¿s.

• Brand Name: ARTERIAL MINI KIT
• Common Device Name: ARTERIAL MINI 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: 17482526
• Report Number: 0001625425-2023-01158
• Device Sequence Number: 8902341
• Product Code: GDF
• UDI-Device Identifier: 00886333215584
• UDI-Public: 00886333215584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/26/2023

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 Model Number: 498107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 07/17/2023; 07/17/2023; 07/17/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/25/2023; 08/28/2023; 09/26/2023; 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