MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC MAHURKAR VASCATH; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 888 135 161

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Notified of vascath with "hole" in it.Catheter clamps were intact and clamped.Aspirated 10 ml from each port, air leak noted.Attached saline syringe to arterial port, leaking noted from small hole where clear tubing attaches to arterial port.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC MAHURKAR VASCATH
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 9426216
• MDR Text Key: 169814885
• Report Number: MW5091493
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 888 135 161
• Device Lot Number: 1904-900 105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 111