MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARGON MEDICAL DEVICES ARTERIAL LINE CATHETER; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 498411B

Device Problems Break (1069); Entrapment of Device (1212)

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 (b)(6) 2022.On (b)(6) 2022, the patient's arterial line dressing was changed per hospital protocol.After removing the previous dressing, a new 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 patient 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 had broken off and remained in the patient's 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 same specific information for the device related to this report.Of note: a previous report with a similar issue was reported for this product to the fda 2/2019.Fda safety report id # (b)(4).

• Brand Name: ARGON MEDICAL DEVICES ARTERIAL LINE CATHETER
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.
• MDR Report Key: 13798377
• MDR Text Key: 287433265
• Report Number: MW5108214
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 498411B
• Device Catalogue Number: 498411B
• Device Lot Number: 11404348
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White