MAUDE Adverse Event Report: COOK INCORPORATED UNIVERSA; CATHETER, NEPHROSTOMY

Model Number G55821

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663)

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

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Patient (pt) in surgery for suprapubic catheter placement.Pt was prepped and draped, cystoscopy had been done, physician started to place the 8 fr malcot suprapubic catheter with the needle that came in the suprapubic catheter set, when the top luer lock connector to the catheter came off/popped off, making the catheter unusable.The entire set was removed from the surgical field and a new stamey suprapubic catheter set was given, which was successfully placed in pt.The set that broke was a single use cook medical malecot suprapubic catheter placement set 8 fr./ 30 cm/ 19g, reference# (b)(4), lot #: 7158156, exp: 07/29/2019.

• Brand Name: UNIVERSA
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7560438
• MDR Text Key: 109784868
• Report Number: 7560438
• Device Sequence Number: 1
• Product Code: EZL
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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: Unknown
• Device Model Number: G55821
• Device Catalogue Number: UMCP-8-30
• Device Lot Number: 7158156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR