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

Model Number	498411B
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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"
• 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: 14139640
• Report Number: 0001625425-2022-00985
• Device Sequence Number: 4793365
• Product Code: GDY
• UDI-Device Identifier: 00886333215652
• UDI-Public: 00886333215652
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-4/13/2020-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown