MAUDE Adverse Event Report: COLOPLAST A/S STAINLESS STEEL PTFE COATED GUIDEWIRE; GASTRO-UROLOGICAL GUIDEWIRE. SINGLE USE

Catalog Number	AE0E38
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn¿t find other complaint on the lot number.Devices met specification prior to release.
Event or Problem Description
According to the available information the guide wire packaging is only welded on one side.The device is not sterile and was not used.Prior to use.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on lot number 9143206.Checking quality databases revealed no anomaly in relation to the described defect.This product is packaged by our hungarian site which was informed about this issue.Hungary's investigation concluded: "this item is produced on the 1ss1 manual cell.According to our process the operator has to place the item inside the package and weld the last side of the pouch.In this case this stepped was missed.Rca: the item had a repackage due to the label was incorrect on the pouch.During this repack the operator missed the welding step on this item.The root cause is human inattention.Action: action: we trained the operators about this kind of failure and the critical processes in production in may, 2024.Training sheet attached.".
Event or Problem Description
According to the available information the guide wire packaging is only welded on one side.The device is not sterile and was not used.Prior to use.

• Brand Name: STAINLESS STEEL PTFE COATED GUIDEWIRE
• Common Device Name: GASTRO-UROLOGICAL GUIDEWIRE. SINGLE USE
• 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: 18953152
• Report Number: 9610711-2024-00069
• Device Sequence Number: 12525431
• Product Code: OCY
• UDI-Device Identifier: 03600040183809
• UDI-Public: 3600040183809
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: AE0E38
• Device Lot Number: 9143206_AE0E381002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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
• Patient Sex: Unknown