MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN DOUBLE LOOP URETERAL STENT KIT IN SILICONE; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number AJ42D4

Device Problem Missing Information (4053)

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

Event Type  malfunction  

Event Description

According to available information, this device was not able to be used due to the box not being sealed.A box did not have a label on receipt, which meant that the box was unsealed.

Manufacturer Narrative

According to the available information, the label was missing from the retail box.In july we received one sealed sample.We note that label on the retail box was missing.After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9197531.Checking the quality databases revealed one corrective and preventive action and one non-conformity: - capa-000030 "quality improvement": the distribution center was trained to good distribution practices in july 2023.- (b)(4) "kitting issues in lpp": the actions are ongoing concerning improvements in the kitting area.The distribution site which packaged kit product was informed about this issue.A resensitization was performed about operator which prepared kit's product in order to avoid this issue.

Event Description

According to available information, this device was not able to be used due to the box not being sealed.A box did not have a label on receipt, which meant that the box was unsealed.

• Brand Name: IMAJIN DOUBLE LOOP URETERAL STENT KIT IN SILICONE
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, 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: 17613840
• MDR Text Key: 321860704
• Report Number: 9610711-2023-00183
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040980880
• UDI-Public: 3600040980880
• Combination Product (y/n): N
• PMA/PMN Number: K213185
• 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: 04/16/2024

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
• Device Catalogue Number: AJ42D4
• Device Lot Number: 9197531_AJ42D43002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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