MAUDE Adverse Event Report: MEDIPLUS LTD S-CATH¿; CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Model Number 5756

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2023

Event Type  malfunction  

Event Description

Foley catheter found to be completely dislodged with balloon deflated.When balloon was tested, there was an obvious leak.

• Brand Name: S-CATH¿
• Type of Device: CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): MEDIPLUS LTD; 131 bay point dr. ne; saint petersburg FL 33704
• MDR Report Key: 17070462
• MDR Text Key: 316599853
• Report Number: 17070462
• Device Sequence Number: 1
• Product Code: QGC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5756
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2023
• Date Report to Manufacturer: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA