MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW DUFO 3WAY SIL 50ML CH22; SILICONE FOLEY CATHETER

Model Number AB63221002

Device Problems Hole In Material (1293); Inflation Problem (1310); Device Dislodged or Dislocated (2923); Failure of Device to Self-Test (2937); No Flow (2991)

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

Event Date 06/04/2016

Event Type  malfunction  

Manufacturer Narrative

One (1) pouch printed ab63221002 lot n°4699213 containing 3 ways folysil with purple valve printed "50ml-4699213" were received for evaluation.After the decontamination with anioxyde 1000,we tested it with air in water and the balloon was deflated and bubbles are gone out of balloon testing revealed the root cause to be due to material.Our rmf criq216 identified the described risk as n°21600 "catheter balloon cannot stay inflated or burst" and it is considered acceptable.Based on the above this complaint is confirmed as a product defect.

Event Description

According to the information received, patient who underwent surgery with ureterostomy left and right, cystoprostatectomy with creation of a neobladder.Implantation of a double current urinary catheter curved in silicone dufour.In intensive care unit, no flow at the catheter.When intensive care staff wanted to uncork the catheter, the catheter remained in their hands.The balloon was deflated.Outside when it was actually a balloon inflation test, it shows a porosity type of failure: the balloon deflates spontaneously.Patient go back to the operative room for the installation of a new catheter.New general anesthesia for the patient.Intensive care was for the consequences and follow up of this operation, not because of the catheter problem.

• Brand Name: X-FLOW DUFO 3WAY SIL 50ML CH22
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S FRANCE; 9 avenue edmond rostand,; sarlat la canéda cedex,, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5765356
• MDR Text Key: 49413662
• Report Number: 9610711-2016-00019
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 03600040144442
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 07/01/2016

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: Physician
• Device Model Number: AB63221002
• Device Catalogue Number: AB63221002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention