MAUDE Adverse Event Report: ARROW ARROW; ARTERIAL LINE

Model Number ASK-04020-UPM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2015

Event Type  malfunction  

Event Description

Dr.Was attempting to place an arterial line in the patient's right radial artery for accurate blood pressure measurements when the arterial catheter broke off in the patient's artery during the insertion attempt.The catheter broke off at the hub.

• Brand Name: ARROW
• Type of Device: ARTERIAL LINE
• Manufacturer (Section D): ARROW
• MDR Report Key: 5001516
• MDR Text Key: 22998626
• Report Number: MW5055362
• Device Sequence Number: 1
• Product Code: DTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/07/2015

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 Operator: Health Professional
• Device Model Number: ASK-04020-UPM
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 243