MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number AB6J20

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  Injury  

Event Description

According to the available information, the patient was catheterized but "lost" the catheter.It was observed that the tip had broken off.The tip was still in the bladder and was removed from the bladder after three days.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9248010.Checking the quality database revealed no anomaly in relation with the described defect.The analysis reveals that the tip on this reference is not glued, the product is made on one piece (tube and tip).The tip's breakage can not occur during production or the packaging's opening.Without sample we cannot do more than documentary investigation which revealed no anomaly in relation with the described defect.A similar case study was performed based on same item number and same defect.No other similar case was found.A risk management framework evaluation was performed and concluded that the risks identified are still acceptable and considered as safe.B3: estimated date.

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18278418
• MDR Text Key: 329866039
• Report Number: 9610711-2023-00257
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: AB6J20
• Device Lot Number: 9248010_AB6J201002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention