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

Catalog Number	AB6324
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information dirt was found inside the packaging.The device was not used.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot n°9102865 indicated in the description.Checking the quality databases revealed no anomaly in connection with the described defect.The sample was not received but with the picture attached, we can see the dirt in the packaging.The product was packaged by our hungarian site who was informed about this issue.The hungarian investigation concluded that: there are 2 possible causes for contamination in packaging: 1.Operators in the production didn't notice the contamination on the catheter.There is a visual inspection in the process to detect this type of failure.The issue was not detected by this control.2.The inner pouch is produced in tunisia and the catheter is placed in to it there.Recently we found more and more items received from tunisia with contamination already on them.Action: we trained the operators about this kind of failure and the critical processes in production in may, 2024.
Event or Problem Description
According to the available information dirt was found inside the packaging.The device was not used.

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Common Device Name: 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: 19143034
• Report Number: 9610711-2024-00088
• Device Sequence Number: 7335201
• Product Code: EZL
• UDI-Device Identifier: 03600040144572
• UDI-Public: 3600040144572
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6324
• Device Lot Number: 9102865_AB63241002
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown