MAUDE Adverse Event Report: COLOPLAST A/S HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number XB6324

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

According to available information, this device had contamination.The item was located on a shelf in a warehouse.The warehouse manager noticed a hair inside the sterile sealed package.No other adverse patient effects were reported.

Event Description

According to available information, this device had contamination.The item was located on a shelf in a warehouse.The warehouse manager noticed a hair inside the sterile sealed package.No other adverse patient effects were reported.

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot n° 8865391.Checking the quality databases revealed no anomaly in connection with the described defect.The production place is a iso class-viii clean area, in this production area everytime have to wear the necessary uniform; means have to wear clean & sterilized jacket and hairnet and shoe too.In case of men have to wear beard cover.This rule is always followed.Even so accidently can be occurrenced to fall hair into the package.Accidently have occurrence to fall hair into the package.This is a manual packaging without automized camera or sensor control, means that only have human responsible to control the whole production process.No camera or sensor have installed to check the complete packaging for hair or foreign material presence.No plan to implement additional packaging control, due to the fact that the packaging is very difficult to filter out by camera system because the packaging is not constant; the packaging material are shiny; no possible to set the camera for this, that would not be a stabile system.It's confirmed that sometimes we receive that raw materials from our suppliers with this phenomenon, that the hair is already part in the pouch.The affected materials have been rejected by us.This materials have already packaged into the first level (primary) packaging, so it's not allowed to opened.The quality alert have been always sent to the supplier.But not easy to filter out all polluted raw material from the batch because the hair is not visible easily that is why accidentally some affected products can be escaped to the market.All involved employees have been informed from this issue, they will focus to filter out the hair infected pouches all the time at production order starting to avoid reoccurrence claims in the future.Continuously inform the supplier about the affected lots to improve their processes, if the received lots affected by hair contamination.

• Brand Name: HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING
• 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: 17722137
• MDR Text Key: 323105498
• Report Number: 9610711-2023-00195
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040260968
• UDI-Public: 3600040260968
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2023

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 Catalogue Number: XB6324
• Device Lot Number: 8865391_XB63241002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Date Device Manufactured: 11/11/2022
• 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): Other