inforMED
InjuryOFF

ARTERIAL LINE KIT

Received Jan 15, 2025 · Event occurred Aug 28, 2024

Report 1423395-2025-00005 · MDR key 21161368

Device

Generic name

Arterial Line Kit

Catalog number

DYNJ47006C

Lot number

24FMA872

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

74 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

UPDATED H10: RELATED REPORT NUMBERS.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2024, DURING PRE-SURGICAL INSERTION OF AN ARTERIAL LINE, WHEN PLACING AN ARTERIAL LINE IN PATIENT, THE WIRE GOT STUCK IN THE CATHETER AND WHEN PULLED OUT OF THE PATIENT, THE WIRE CAME UNWOUND. THERE WAS NO HARM TO PATIENT. THE DEVICE WAS REMOVED AND THEY OBTAINED A NEW ARTERIAL LINE FOR REINSERTION. THE PROCEDURE WAS COMPLETED ON THE OPPOSITE ARM AND THE PROCEDURE WAS COMPLETED. THE VFACILITY STATED THERE WAS NO SERIOUS INJURY OR MEDICAL FOLLOW-UP. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE FACILITY ON (B)(6) 2024, DURING PRE-SURGICAL INSERTION OF AN ARTERIAL LINE, WHEN PLACING AN ARTERIAL LINE IN PATIENT, THE WIRE GOT STUCK IN THE CATHETER AND WHEN PULLED OUT OF THE PATIENT, THE WIRE CAME UNWOUND. THERE WAS NO HARM TO PATIENT.