MAUDE Adverse Event Report: ANGIODYNAMICS, INC. GENERAL DRAINAGE SUPRAPUBIC CATHETER 12F LOCKING PIGTAIL; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Lot Number 5683610

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2021

Event Type  malfunction  

Event Description

The tip of the catheter broke off and got retained while attempting to be removed.Imaging showed the tip was noted to be kinked.

• Brand Name: GENERAL DRAINAGE SUPRAPUBIC CATHETER 12F LOCKING PIGTAIL
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 12438551
• MDR Text Key: 270503032
• Report Number: MW5103745
• Device Sequence Number: 1
• Product Code: GBO
• 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: 09/02/2021

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 Lot Number: 5683610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2021
• 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: 36 YR
• Patient Weight: 152