MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number AA6114

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the available information the patient pulled out an indwelling catheter, and was found to be missing the balloon, which had been cut off.The balloon was not found in the room or the patient after endoscopy for cystoscopy was performed.The patient was re-catheterized.

Event Description

According to the available information the patient pulled out an indwelling catheter, and the catheter was found to be missing the balloon, which had been cut off.The balloon was not found in the room.The patient was referred to endoscopy for cystoscopy and the patient was re-catheterized.

Manufacturer Narrative

Estimated date after receiving this complaint, we searched for other complaints and we found none regarding the lot number 9253806.After disinfection of the used sample, it was observed that balloon was burst.We received a documentary investigation from our tunisian subcontractor: the root cause was probably due to a defect in the balloon¿s raw material.Checking the quality databases revealed this type of defect is known and closely monitored a similar case study was performed based on same item number and same defect [balloon burst] over the last four years; no similar cases were found.A risk assessment was performed and concluded that the residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.Corrections: b1/2: report type corrected from malfunction to serious injury.B5: incident description.H1: type of report correct from malfunction to serious injury.

• Brand Name: FOLYSIL SILICONE 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: 18149935
• MDR Text Key: 328297358
• Report Number: 9610711-2023-00248
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• 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
• Report Date: 11/16/2023

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: Health Professional
• Device Catalogue Number: AA6114
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• 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