MAUDE Adverse Event Report: ISOMEDIX OPERATIONS INC. T-DOC URODYNAMIC CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Catalog Number TDOC-7FD

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 03/10/2017

Event Type  malfunction  

Event Description

At the "y" where the two catheters meet, it was leaking from there.We were unable to use, there must have been a small hole in the tubing at that point.

Manufacturer Narrative

Unique device identifier (udi): for type of device: device, cystometric, hydraulic.

Event Description

At the "y" where the two catheters meet, it was leaking from there.We were unable to use, there must have been a small hole in the tubing at that point.

• Brand Name: T-DOC URODYNAMIC CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): ISOMEDIX OPERATIONS INC.; 9120 south 150 east; sandy UT 84070
• MDR Report Key: 6449177
• MDR Text Key: 71382365
• Report Number: 6449177
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: TDOC-7FD
• Device Lot Number: 161496
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2017
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1