MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL MINI KIT

Model Number 498107

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  Injury  

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 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.

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 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.

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 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.

Manufacturer Narrative

Adding updated product and udi number.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 320762886
• Report Number: 0001625425-2023-01158
• Device Sequence Number: 1
• Product Code: GDF
• UDI-Device Identifier: 00886333215584
• UDI-Public: 00886333215584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/17/2023
• 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