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

Model Number 498411B

Device Problems Break (1069); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 02/27/2022

Event Type  malfunction  

Event Description

The arterial line was placed on the.The patients arterial line dressing was changed per hospital protocol after removing the previous dressing.Anew dressing was applied the arterial line was functioning properly for a few minutes after the dressing change as the arterial line tubing was being secured.The patent bent her wrist and the arterial line was inadvertently removed in the process after the bleeding was managed.The dressing was removed and immediately it was recognized that the majority of the arterial line catheter bad broken off and remained in the patents artery.The patient was subsequently taken to the operating room for removal of the retained portion of the arterial catheter, the included manufacturing info (serial lot number) was retrieved from an arterial line kit on the day of the event.Unsure if it is the specific information for the device related to this report of note previous report with a similar issue was reported for this product to the fda 2/2019.

Manufacturer Narrative

Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

Event Description

The arterial line was placed on on the.The patients arterial line dressing was changed per hospital protocol after removing the previous dressing.Anew dressing was applied the arterial line was functioning properly for a few minutes after the dressing change as the arterial line tubing was being secured.The patent bent her wrist and the arterial line was inadvertently removed in the process after the bleeding was managed.The dressing was removed and immediately it was recognized that the majority of the arterial line catheter bad broken off and remained in the patents artery.The patient was subsequently taken to the operating room for removal of the retained portion of the arterial catheter, the included manufacturing info (serial lot number) was retrieved from an arterial line kit on the day of the event.Unsure if it is the specific information for the device related to this report of note previous report with a similar issue was reported for this product to the fda 2/2019.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One extension tubing was returned for review.Visual inspection observed signs of use with the presence of dried bodily fluids on the product.The hub of the arterial catheter was returned attached to the male luer of the extension tubing.The hub was removed from the luer by the analyst and the strain relief was found to be attached to the hub.The strain relief was removed from the hub by the analyst to make a closer observation of where the tubing was once attached to the hub.The tubing exhibited jagged edges which is indicative of a tensile force being applied to the product.The section of catheter that was removed from the patient was also returned and the end of the tubing that was proximal to the patient was bent and also exhibited jagged edges.The most probable cause for the breakage of the catheter was most likely due to a tensile force on the catheter as a result of patient movement.The customer stated "the patent bent her wrist and the arterial line was inadvertently removed in the process".Since this issue was most likely related to an event in the user environment and not a manufacturing error, no corrective action will be taken.

• Brand Name: ARTERIAL LINE KIT 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: 14139640
• MDR Text Key: 295899209
• Report Number: 0001625425-2022-00985
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00886333215652
• UDI-Public: 00886333215652
• 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: Other,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/03/2022
• Device Model Number: 498411B
• Device Catalogue Number: 498411B
• Device Lot Number: 11404348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1625425-4/13/2020-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other